ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP

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FREEDOM OF INFORMATION REQUEST

FOI request into compliance of Trust’s VTE prevention policies

with national VTE prevention best practice

Name: Stephen Jenkins

Position: Consultant Haematologist

Acute Trust: Dudley Group of Hospitals NHS Foundation Trust

Email: Stephen.jenkins@dgh.nhs.uk

Please note that additional paper or electronic copies are available on request

from the All-Party Parliamentary Thrombosis Group secretariat Please return your completed response to the All-Party Parliamentary Thrombosis Group secretariat:

James Le Grice All-Party Parliamentary Thrombosis Group Secretariat c/o Insight PA 52 Grosvenor Gardens London SW1W 0AU Email: VTEaudit@insightpa.com Tel: 020 7824 1850 Fax: 020 7824 1851

Under the Freedom of Information Act 2000, the All-Party Parliamentary Thrombosis Group writes to request the following information:

ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP

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QUESTION ONE – WRITTEN VTE PREVENTION POLICY

a) Does your Trust have a written policy in place for preventing and managing the risks of VTE for

adult hospital admissions? If yes, please attach a copy of the policy. (Place an X in one box)

Yes, the policy is attached.

X

No

b) If your Trust has a written VTE prevention policy in place, does it include the seven principles of best practice contained within the NICE quality standard on VTE prevention, which are set out below? (Place an X in one box, only answering yes if all seven statements are included within your policy)

Statement 1: All patients, on admission, receive an assessment of VTE and bleeding risk using the clinical risk assessment criteria described in the national tool.

Statement 2: Patients/carers are offered verbal and written information on VTE prevention as part of the admission process.

Statement 3: Patients provided with anti-embolism stockings have them fitted and monitored in accordance with NICE guidance.

Statement 4: Patients are re-assessed within 24 hours of admission for risk of VTE and bleeding.

Statement 5: Patients assessed to be at risk of VTE are offered VTE prophylaxis in accordance with NICE guidance.

Statement 6: Patients/carers are offered verbal and written information on VTE prevention as part of the discharge process.

Statement 7: Patients are offered extended (post hospital) VTE prophylaxis in accordance with NICE guidance.

Yes

X

No

ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP

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QUESTION TWO – ROOT CAUSE ANALYSIS

According to Service Condition 20 of the NHS Standard Contract 2013/14, the provider must:

“perform root cause analysis of all confirmed cases of pulmonary embolism and deep vein thrombosis

acquired by Service Users while in hospital (both arising during a current hospital stay and where there

is a history of hospital admission within the last 3 months, but not in respect of Service Users admitted

to hospital with a confirmed venous thromboembolism but no history of an admission to hospital within

the previous 3 months...”

The provider must report the results of those root cause analyses monthly in accordance with Schedule

6 Part C of the Reporting Requirements.

a) Does your Trust submit monthly reports on the outcome of all root cause analyses preformed

pursuant to Service Condition 20 of the NHS Standard Contract 2013/14? (Place an X in one box)

Yes

X

No

b) If yes, please provide details of the reports from the last three months:

Date of report submission Number of root cause analyses

included in the report

Total number of cases of

hospital-acquired DVT and PE

in your Trust in the given

month

Report 1 April 2013 (reported June) 6 7

Report 2 May 2013(reported July) 12 16

Report 3 June2013(reported August) 1 2

8 WEEK TIMESCALE GIVEN FOR COMPLETION OF RCAS FROM DATE ON RADIOLOGY, ICD AND

BEREAVEMENT OFFICER REPORTS

ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP

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QUESTION THREE – NHS LITIGATION AUTHORITY RISK MANAGEMENT STANDARDS

a) When was your Trust last assessed by the NHS Litigation Authority for performance against its

Risk Management Standards?

November 2012

b) During this latest assessment, what level did your Trust score on the VTE risk management

standard (Criterion 5.9) (Place an X in one box)

Level 1

X

Level 2

Level 3

ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP

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QUESTION FOUR – NATIONAL VTE PREVENTION CQUIN GOAL

0.5 per cent of the value for all healthcare services commissioned through the NHS Standard Contract is

linked to the national CQUIN goals, where these apply. There are four national CQUIN goals for 2013/14,

one of which is:

“Venous thromboembolism – 95 per cent of patients being risk assessed and achievement of a locally

agreed goal for the number of VTE admissions that are reviewed through root cause analysis.”

a) Was a CQUIN payment (or a proportion of it) withheld from your Trust due to non-compliance

with the National VTE Prevention CQUIN Goal in 2013/14? (Place an X in one box)

Yes

No

x

b) The National VTE Prevention CQUIN Goal has been in place, in different forms, since 2010. Has a

CQUIN payment (or a proportion of it) been withheld from your Trust due to non-compliance with

the National VTE Prevention CQUIN Goal in any of the following years? (Place an X in appropriate

boxes)

2010/11

Yes

No

x

2011/12

Yes

No

x

2012/13

Yes

No

X

ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP

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QUESTION FIVE – PATIENT INFORMATION

NICE Quality Standard on VTE Prevention stipulates that patients/carers should be offered verbal

information on VTE prevention as part of the admission as well as the discharge processes.

a) Does your Trust undertake audit of whether verbal AND written information on VTE prevention is

offered as part of the admission AND discharge processes to patients identified through VTE risk

assessment as being at risk of VTE? If yes, please provide the details of the last audit carried out.

(Place an X in one box)

Yes, the details of the audit are below

x

No

Audit Details

Date: August 2013

Results: Number of patients receiving verbal and written information

VERBAL WRITTEN BOTH NONE

5 3 15 42

7.7% 4.61% 23.07% 64.62%

Number of patients receiving information audited monthly as part of Thromboprophylaxis audit which

also looks at VTE assessment and prescription/delivery of appropriate prophylaxis

10 patients selected randomly from ward areas on a rolling programme so all areas audited quarterly

b) As part of your patient information dissemination programme, does your Trust use the

‘Preventing hospital-acquired blood clots’ leaflet produced by the NHS in conjunction with

Lifeblood: The Thrombosis Charity? (Place an X in one box)

Yes

No

x

Trust Leaflets utilised including General leaflet and one specific to Maternity

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THE DUDLEY GROUP OF HOSPITALS THROMBOPROPHYLAXIS GUIDELINE: Surgery & the Peri-operative Period This is one of several Trust-wide guidelines related to the management of thrombotic risk and anticoagulation that has been produced by the Thrombosis Committee of Dudley Group of Hospitals NHS Foundation Trust. Reference to these should be made for other patient groups.

• Surgery and the peri-operative period • Medical Admissions and Inpatients • During Pregnancy • Post Caesarean Section • After Vaginal Delivery • For patients undergoing ECT • Use of Compression Hosiery • Management of Warfarin Therapy during Surgery & Invasive Procedures • Referral to DVT Assessment Suite • Management of Suspected Venous Thromboembolism • Treatment of Proven Venous Thromboembolism

1.0 SCOPE AND GENERAL POINTS OF NOTE This document is a guideline. Like all guidelines it should be used in conjunction with your clinical assessment, to help reach an informed decision regarding appropriate thromboprophylaxis for individual patients. The guideline complies with NICE clinical Guideline 92 Venous Thromboembolism: Reducing the risk (Jan 2010), and is informed by the Department of Health requirement to risk assess all adult patients admitted to hospital including all day case procedures. (DH; Guidance notes to accompany VTE risk assessment data collection. 21st May 2010) The above guidance clearly state the need for risk assessment of all patients (aged 18yrs and older) admitted to hospital, including those admitted for non-operative day case procedures eg endoscopy. All these patients should be able to readily access information on VTE risk, VTE prevention, symptoms and signs of VTE and what to do if they suspect VTE. In addition and when appropriate, patients should receive specific additional interventions to reduce their risk of developing VTE. These interventions would be in addition to general good advice and care and often include one or more of Graduated Compression Stockings (GCS/TEDs), LMWH prophylaxis (Enoxaparin), regional anaesthetic techniques and Intermittent Pneumatic Compression (IPC). This document is divided into 2 main sections

• Risk Assessment (RA), Patient Information and General Measures; and • Specific Additional Interventions for those at significant risk; mainly Graduated

Compression Stocking (GCS/TEDs) +/- LMWH (enoxaparin), +/- Intermittent Pneumatic Compression.

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2. RISK ASSESSMENT (RA), PATIENT INFORMATION AND GENERAL MEASURES 2.1 Risk Assessment (RA) Regular risk assessment is the cornerstone of identifying high risk patients and guiding specific intervention(s). Of equal importance it acts to inform and remind patients and staff about VTE even in lower risk groups where best practice is to give advice and ensure routine care is delivered to a high standard. Therefore it is important to risk assess every patient admitted to hospital. This can be done in one of two ways. 2.1.1 Cohort RA Some lower risk groups will be risk assessed as a cohort based on procedure type and day-case procedure. These patients can routinely expect their care to include general measures to reduce risk (eg avoid dehydration (where appropriate) and encourage early mobilisation) as well as access to advice and information on VTE risk, prevention, recognition and what action to take if it is suspected. However they would not usually require any of the specific additional interventions listed in 3.0 below. Cohort RA will be undertaken by members of the Thrombosis Committee in consultation with specialty leads in clinical areas and be agreed with the Medical Director. Although it would be extremely uncommon for patients within these cohorts to require specific additional interventions, exceptions are possible; for example, if a high risk patients undergoes a day case procedure that results in a significant reduction in mobility then staff should arrange an individual risk assessment and discuss thromboprophylaxis with the Anticoagulation service (Extn xxxx; bleep xxxx). Cohorted groups include the following:

• Opthalmology day cases, excluding those done under GA. • All operative day cases either done under LA infiltration only or requiring no

anaesthetic. • Day Case investigations and procedures done in the endoscopy suite. • Day Case investigations and procedures within radiology including those

requiring GA. 2.1.2 Individual Risk Assessment The following groups of patient require an individual risk assessment

• All patients (emergency and elective) admitted to hospital for at least 1 overnight stay.

• All operative day case admissions having surgery that is not performed either without anaesthesia or with LA infiltration only. i.e all day-case procedures done under GA (except where excluded in 2.1.1 above), nerve block or regional anaesthesia will require an individual RA

Individual Risk assessments should be done using the Trust ‘VTE and bleeding risk assessment tool’ (appendix 1). The risk assessment tool helps the clinician balance the risks of bleeding and venous thrombosis. For in-patients the RA should be repeated at 24 hours and again whenever the clinical condition changes. This is especially important for surgical

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patients as an operative procedure will clearly increase the risk of bleeding but that risk will diminish rapidly postoperatively when the patient often enters a prothrombotic state. Unexpected admissions from the DCU (Day Case Unit) or the need to prolong a short stay are examples. 2.1.3 Using the VTE and Bleeding Risk Assessment Tool for individual Risk assessment Appendix 1 Assess VTE Risk Does the patient have one of the 5 surgical ‘triggers’ to identify them as high risk of VTE? If ‘yes’ continue risk assessment. If ‘no’ identify patient as not needing specific additional interventions; risk assessment complete Assess Bleeding Risk Does the patient have one or more of the risk factors for bleeding? If ‘yes’ the patient is at increased risk of bleeding if enoxaparin is given Do not offer enoxaparin to these patients unless the risk of VTE outweighs the risk of bleeding Balance Risk VTE vs Risk Bleeding Consider contraindications to GCS/TEDs and enoxaparin, then choose one of the 5 options on the risk assessment tool. 2.1.4 Individualising thromboprophylaxis Risk assessments can be further individualised by adding comments to the drug chart. Examples include: omitting or delaying one dose of enoxaparin because of a planned invasive procedure around the time it is due, or omitting a dose every time a bleeding risk factor is ‘breached’ such as a high INR. 2.1.5 Responsibilities for performing individual risk assessments and delivering thromboprophylaxis.

• The risk assessment tool must be completed, signed and dated by the doctor admitting the patient to the ward. Where a patient is admitted electively through the pre-operative assessment clinic or onto the Day-Case Unit, trained nurses will complete the risk assessment. However the admitting doctor must review this and confirm there have been no changes that might affect the risk assessment.

• In all cases Medical staff will be responsible for reviewing the risk assessment tool and when appropriate, prescribing the GCS/TEDs and LMWH (enoxaparin 40mg at 18:00). This should be done as soon as possible after risk assessment is complete.

• Nursing staff are responsible for confirming there are no contra-indications to TEDs/GCSs and for the fitting and daily checking of these. If at any time the nurse believes a contra-indication exists/develops this should be discussed with the medical team and the prescription amended/deleted as appropriate. This must be clearly recorded in the nursing process.

• Below knee stockings should only be used where patients are unable to tolerate full length or other circumstances exist which make above knee stockings ineffective or impractical.

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• Reassess patients’ risks of bleeding and VTE within 24 hours of admission and whenever the clinical situation changes, to: − ensure that the methods of VTE prophylaxis being used are suitable − ensure that VTE prophylaxis is being used correctly − identify adverse events resulting from VTE prophylaxis

2.2 Information and general measures 2.2.1 All patients including low risk cohorted groups All patients should be provided with or have ready access to written information explaining what VTE is, the risks associated with a hospital procedure, what general measures will help prevent VTE (especially good hydration and early mobilization), what the symptoms and signs of VTE are and who to contact if they suspect VTE. This should be backed up by verbal information from staff. 2.2.2 Information for individually risk assessed patients who may require specific additional interventions Patient information before and at admission If patients are well informed they will better understand what is needed not only in terms of mechanical and chemical prophylaxis but also in what they can do to reduce their risk of VTE. Before starting VTE prophylaxis, offer patients and/or their families or carers verbal and written information on:

• the risks and possible consequences of VTE • the importance of VTE prophylaxis and its possible side effects • the correct use of VTE prophylaxis (for example, anti-embolism stockings, foot

impulse or intermittent pneumatic compression devices, these may be used if there is a contra-indication to LMWH)

• how patients can reduce their risk of VTE (such as keeping well hydrated and, if possible, exercising and early mobilisation).

• If the patient does not already have the Trust pre-admission leaflets on ‘Preventing Blood Clots in Hospital’ and ‘Patient Information’ http://thehub/trustdocuments/clinicalpolicies/Trustwide%20Policies/VTE%20Policy%20Oct%202010.pdf give them a copy on admission

Patient Information about Anaesthesia

• Consider and discuss regional anaesthesia in addition to other methods of VTE prophylaxis for high risk patients, as it carries a lower risk of VTE than general anaesthesia. Take into account patient preferences, suitability for regional anaesthesia and any other planned method of VTE prophylaxis.

• If regional anaesthesia is used, plan the timing of pharmacological prophylaxis to minimise risk of epidural haematoma. If antiplatelet or anticoagulant agents are being used or their use is planned, refer to Trust guidance http://thehub/departments/clinicalhaematology/Published%20Documents/Antiplatelet%20guidelines%20Dec10.pdf ‘ANTIPLATELET AGENTS AROUND THE TIME OF SURGERY: Guidance on if and when to stop treatment perioperatively’) and/or the summary of product characteristics for guidance about safety and timing of these agents in relation to regional anaesthesia.

Patient information for discharge

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As part of the discharge plan, offer patients and/or their families or carers verbal and written information on:

• the signs and symptoms of deep vein thrombosis and pulmonary embolism • the importance of seeking medical help and who to contact if deep vein

thrombosis, pulmonary embolism or another adverse event is suspected. • the correct and recommended duration of use of VTE prophylaxis at home (if

discharged with prophylaxis, at present this is only routinely necessary following elective knee or hip replacement, or sometimes after major cancer surgery in abdomen or pelvis )

• the importance of using VTE prophylaxis correctly and continuing treatment for the recommended duration (if discharged with prophylaxis)

• the signs and symptoms of adverse events related to VTE prophylaxis (if discharged with prophylaxis)

• the importance of seeking help and who to contact if they have any problems using the prophylaxis (if discharged with prophylaxis)

3.0 SPECIFIC ADDITIONAL INTERVENTIONS These broadly fall into the following categories. Routine:

• Graduated Compression Stockings (GCS/TEDs) • LMWH (Enoxaparin) as a once daily subcutaneous injection

Occasional: • Regional Anaesthesia • Intermittent Pneumatic Compression (IPC); usually when LMWH

contraindicated. • Rivaroxaban (an oral direct inhibitor of factor Xa, licensed for

thromboprophylaxis following hip or knee arthroplasty), is presently recommended only for extended prophylaxis in needle phobic patients having these operations

• Temporary inferior vena caval filters should be considered in patients who are at very high risk of VTE (such as patients with a previous VTE event or active malignancy) if mechanical and pharmacological VTE prophylaxis contraindicated.

Do not regard aspirin or other antiplatelet agents as adequate prophylaxis for VTE. 3.1.0 Graduated Compression Stockings (GCS/TEDs) These are indicated and, except where contra-indications exist, appropriate for nearly all elective and emergency surgical inpatients. It is vital that they are fitted properly and the patient wears them continuously. A member of staff trained in their use should give advice and help to all patients; showing how to wear them correctly. They should be removed and the integrity of the patient’s skin checked by a person trained in their use at least daily and refitted / replaced as necessary. Soiled stockings should be replaced immediately. Where a contra-indication exists alternative methods of thromboprophylaxis should be considered; see 3.1.1 below 3.1.1 Contraindications to TEDs / GCS

o Suspected or proven peripheral arterial disease o Peripheral arterial bypass grafting o Peripheral neuropathy or other causes of sensory impairment

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o Leg ulceration/wounds or other conditions where stockings may cause/worsen damage

o Cardiac failure o Severe leg oedema of any cause o Stroke o Major limb deformity or unusual leg size/shape preventing correct fit

Contra-indications to the use of GCS are unusual. It would be expected that the contraindication was agreed between nursing and medical staff and clear documentation is made on the risk assessment tool, drug chart or medical notes stating

1. Details of the contraindication and 2. What alternative method (if any) of thromboprophylaxis is deemed

appropriate Not all contraindications are fixed and it maybe after appropriate treatment and re-assessment it is possible to introduce GCS.

3.2.0 LMWH (Low Molecular Weight Heparin) At present the LMWH used as thromboprophylaxis within DGOH NHS Foundation Trust is Enoxaparin. The standard dose is 40mg subcutaneously given at 18:00 daily at least until discharge. 3.2.1 Contraindications to Enoxaparin All patients who have any of the following

o Active bleeding o Acquired bleeding disorders (eg acute liver failure) with abnormal clotting

indices o Concurrent use of anticoagulants known to increase the risk of bleeding (such

as warfarin with INR > 2) o Lumbar puncture/epidural/spinal anaesthesia, neurosurgery or eye surgery

within the previous 4 hours or expected within the next 10 hours o Acute stroke o Thrombocytopenia (platelets < 75 x 10 /I) o Uncontrolled systolic hypertension (≥ 230/120 mmHg) o Untreated inherited bleeding disorders (such as haemophilia or von

Willebrand’s disease) o Known hypersensitivity to enoxaparin o Heparin Induced Thrombocytopenia (HIT) type 2 (Discuss with consultant

haematologist) CAUTION adjustment of dose or timing may be necessary with renal impairment, hepatic insufficiency or increased bleeding potential If LMWH is appropriate but there is a contra-indication then an Intermittent compression device should be prescribed (to be worn continuously, when patient not mobilising) for the same duration that LMWH would have been given. If the contra-indication persists this may involve use after discharge for some patients. Trials which have shown efficacy for these types of device have had average usage of approximately 16 hours per day.

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Contra-indications to the use of enoxaparin are unusual. It would be expected that the contraindication was agreed between nursing and medical staff and clear documentation is made on the risk assessment tool, drug chart or medical notes stating

1. Details of the contraindication and 2. What alternative method (if any) of thromboprophylaxis is deemed

appropriate. Not all contraindications are fixed and it maybe after appropriate treatment and re-assessment it is possible to introduce enoxaparin. Likewise if a contra-indication develops during treatment it may be necessary to stop or change prophylaxis; eg if a patient developed a significant bleed stop enoxaparin and consider replacing with an IPC device. 3.3.0 Timing of LMWH (Enoxaparin) 3.3.1 Patients admitted night before surgery: It is recommended that patients remain fully mobile at home until the morning of surgery and therefore it should not usually be necessary to admit a patient the night before simply to receive LMWH prophylaxis. However if patients need to be admitted for other reasons then they should, when indicated, receive enoxaparin starting 18:00 the evening before surgery. This will achieve effective thromboprophylaxis combined with minimal additional risk of bleeding complications at the time of regional anaesthesia and surgery. If it is not possible to give a patient enoxaparin at 18:00 (for example, not yet prescribed or not yet admitted) and they are scheduled for surgery the next day the medical staff should perform a risk assessment to decide on when or if a pre-operative dose should be given. The following table may help in reaching this decision, remembering that patient and procedure specific risk factors may on occasions override these. Latest time pre-operative enoxaparin can normally be given

Planned Operation Start Time

22:00 08:00 – 10:00 24:00 10:00 – 13:00 03:00 Afternoon list Where the routine dose has been missed at 18:00 it is expected that nursing staff would request medical staff attend to confirm/perform a risk assessment and prescribe prophylaxis if indicated. Failure to perform a timely risk assessment, prescribe appropriate prophylaxis if indicated, or deliver such prophylaxis when prescribed should be considered a critical incident. If enoxaparin is not administered at least 10 hours ahead of planned surgery the first dose should normally be withheld until at least 4 hours postoperatively and at such a time that significant bleeding has been excluded. Senior medical and nursing staff responsible for the patient should oversee this to ensure appropriate standards are maintained. Enoxaparin should be continued daily at 18:00 until discharge from hospital, or longer for some patient groups. 3.3.2 Patients admitted on the morning of surgery:

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All patients admitted on the day of surgery, who are eligible for LMWH prophylaxis, should receive their first dose of enoxaparin between 14:00 and 24:00 hours on the day of surgery. It should only be given when the following are confirmed:

1. At least 4 hours has elapsed post operatively and 2. There are neither clinical signs of active bleeding nor clinical signs of an

important bleed (for example neurological deficit after spinal surgery). Enoxaparin should be continued from the following day at 18:00 and daily thereafter until discharge from hospital, or longer for some patient groups 3.3.3 Emergency patients: Patients, who are eligible for LMWH prophylaxis and go to theatre that day should have their first dose

1. no sooner than 4 hours post-operatively and 2. when there are neither clinical signs of active bleeding nor clinical signs of

an important bleed (for example neurological deficit after spinal surgery)

In addition to points 1. and 2. above the following table may be used as a guide by the clinician to decide when and how much enoxaparin to prescribe to patients undergoing emergency out of hours surgery (or elective surgery finishing late in the day); remembering that patient and procedure specific risk factors may on occasions override these. Operation Finish Time

1st post-op dose (40mg enoxaparin)

2nd post-op dose Subsequent daily doses as per guidelines (40mg @ 18:00)?

16:00 – 19:00 20:00 – 01:00 40mg enoxaparin @ 18:00 (i.e back on normal guideline)

Yes

19:00 – 21:00 23:00 – 03:00 20-40mg enoxaparin @ 18:00

Yes

21:00 – 02:00 01:00 – 08:00 20-40mg enoxaparin @ 18:00 to 24:00

Yes

02:00 – 04:00 06:00 – 10:00 20mg enoxaparin @ 22:00 – 24:00

Yes

Patients admitted, who are eligible for LMWH prophylaxis, but not expected to be operated on that day should receive their recommended dose from 18:00 the evening of admission; for patients admitted late in the day the LMWH can be given up to 24:00 hours. 4.0 SPECIAL SITUATIONS Below is brief guidance on specific issues which impact on the information so far contained in this guideline. If in any complex situation you are unclear about how to proceed discuss it with senior members of your team, the anticoagulation service or a consultant Haematologist.

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4.1.0 Women on oestrogen containing oral contraceptives or HRT Reaching a decision on the balance of risk between VTE and, for example unwanted pregnancy, needs to be individualised for each patient and operative setting. Options include; stopping oestrogen-containing contraceptives or HRT 4 weeks before surgery or, after the patient has fully understood any additional risk, agreeing to proceed with or without additional specific additional interventions (GCS/TEDs +/- Enxaparin).

4.1.1 Pregnant women admitted for incidental surgery or as a surgical emergency These patients must be managed jointly with the Obstetrician and advice sort from a Consultant Haematologist and the Anticoagulation service. 4.1.2 Pre-existing antiplatelet therapy Assess risks and benefits of stopping pre-existing antiplatelet therapy before surgery: see Trust guideline ‘ANTIPLATELET AGENTS AROUND THE TIME OF SURGERY: Guidance on if and when to stop treatment perioperatively’ http://thehub/departments/clinicalhaematology/Published%20Documents/Antiplatelet%20guidelines%20Dec10.pdf and consider involving the multidisciplinary team in the assessment. 4.1.3 Renal failure: Patients with significant renal impairment or renal failure will accumulate LMWH and may need only occasional dosing. Such patients should be discussed with a Consultant Haematologist and advice sort on frequency of dosing and monitoring. 5.0 EXTENDED THROMBOPROPHYLAXIS 5.1.1 Elective Hip and Knee Replacement At present only patients who have undergone elective knee or hip replacement routinely require extended thromboprophylaxis. These patients should receive detailed information and counselling at the ‘hip and knee education/assessment clinic’ shortly after being listed for surgery. This should include using the self injection model. After admission they should receive further training and have an assessment of competence prior to discharge. THR patients receive a total of 28 days prophylaxis and TKR patients 10. 5.1.2 Extended Prophylaxis in needle phobic patients A small sub-group of the patients who need extended thromboprophylaxis are needle phobic and unable to learn how to self-inject. Rivaroxaban (an oral direct inhibitor of factor Xa, licensed for thromboprophylaxis following hip or knee arthroplasty) should be offered to provide extended thromboprophylaxis in these patients. It should be prescribed as Rivaroxaban 10mg once daily and given at 18:00. 5.1.3 Other patients who may warrant extended prophylaxis Patients undergoing major abdominal or pelvic cancer surgery should be considered for extended (28day) thromboprophylaxis. These patients should receive advise and training on self injection of enoxaparin and the correct use of GCS/TEDs during the

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pre-assessment process and during the in-patient stay. Liaison with district nurses and the anticoagulation service may be necessary. On occasions clinicians may feel it appropriate to offer other patients extended prophylaxis. They should discuss this option on a case by case basis with a consultant Haematologist and the anticoagulation service. 6.0 USING IN-THEATRE IPC IN ADDITION TO THIS GUIDANCE See: Addendum 1 ‘Intra-operative addition of Intermittent Pneumatic Compression (IPC) to Trust standard thromboprophylaxis in high risk patients’. Available via Thrombosis committee or in theatre from matron Steve Randall. Originator: Consultant Anaesthetist On behalf of the Thrombosis Committee Date of Ratification: August 2010 Date of Review: August 2013 References 1. Drugs in the peri-operative period: 3 - Hormonal contraceptives and hormone replacement therapy. Drugs and Therapeutics Bulletin 1999;37(10):78-80. 2. Bergqvist D, Benoni G, Bjorgell O, Fredin H, Hedlundh U, Nicolas S, et al. Low-Molecular-Weght Heparin (Enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement. New England Journal of Medicine 1996;335:696-700. 3. Checketts MR, Wildsmith JAW. Central nerve block and thromboprophylaxis-is there a problem? British Journal of Anaesthesia 1999;82(2):164-167. 4. Clagett GP, Anderson Jr FA, Geerts W, Heit JA, Knudson M, Lieberman JR, et al. Prevention of venous thromboembolism. Chest 1998;114:531S-560S. 5. Roderick P et al. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis. Health Technology Assessment 2005; vol9: No 49 6. Scottish Intercollegiate Guidelines Network (SIGN) Guideline No 62: Prophylaxis of Venous Thromboembolism. 2002. 7. Geerts WH, Pineo GF et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep; 126 (3 suppl): 338S-400S 8. The VERITY Steering Committee. The Third Venous Thromboembolism Registry Report. VERITY 2005 9. Nicolaides AN, Fareed J et al. Prevention and Treatment of Venous thromboembolism International Consensus Statement (Guidelines according to scientific evidence). International Angiography 2006 Vol 25 No2: 101-61 10. NICE clinical guideline 92 Venous thromboembolism: reducing the risk. Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. NICE Jan 2010 Appendix 1: VTE and bleeding risk assessment tool http://thehub/departments/clinicalhaematology/Published%20Documents/VTE%20Risk%20Assessment%20v5.pdf

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THE DUDLEY GROUP OF HOSPITALS THROMBOPROPHYLAXIS GUIDELINE MEDICAL ADMISSIONS AND INPATIENTS 1. SCOPE AND GENERAL POINTS OF NOTE This document is a guideline. Like all guidelines it should be used in conjunction with your clinical assessment, to help reach an informed decision regarding appropriate thromboprophylaxis for individual patients. The guideline complies with NICE clinical Guideline 92 Venous Thromboembolism: Reducing the risk (Jan 2010). In complex cases seek advice of anticoagulation service: Extension 2380 This is one of several Trust-wide guidelines related to the management of thrombotic risk and anticoagulation that has been produced by the Thrombosis Committee of Dudley Group of Hospitals NHS Trust. Reference to these should be made for other patient groups. ‘Ctrl and click’ the links below.

Surgery and the peri-operative period -http://thehub/departments/clinicalhaematology/Published%20Documents/Sx%20%20periop%20thromboprophylaxis%20Final%20Oct2010.pdf

During Pregnancy- http://thehub/departments/maternity/Antenatal/thromboprophylaxis%20during%20the%20antenatal%20intrapartum%20and%20postnatal%20period%20(2).pdf Post Caesarean Section -

http://thehub/departments/Documents/Thromboprophylaxis%20following%20LSCS.doc

After vaginal delivery -

http://thehub/departments/Documents/Thromboprophylaxis%20following%20vaginal%20delivery.doc

For patients undergoing ECT- http://thehub/departments/clinicalhaematology/Published%20Documents/Warfarin%20Therapy.pdf

Use of Compression Hosiery -http://thehub/departments/clinicalhaematology/Published%20Documents/Graduated%20Compression%20Hosiery%20guidleine%202009.pdf

Management of Warfarin Therapy during Surgery and Invasive Procedures -

http://thehub/departments/clinicalhaematology/Published%20Documents/Warfarin%20Therapy.pdf

Referral to DVT Assessment Suite- http://thehub/departments/clinicalhaematology/Published%20Documents/Direct%20DVT%20referral%20policy%20November%202009.pdf

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Pregnant women admitted with an intercurrent medical illness should be assessed using this guideline and must be managed jointly with the Obstetric team and advice sort from a Consultant Haematologist or the Anticoagulation service. The obstetric team and anticoagulation service must be notified if a pregnant woman already on thromboprophylaxis is admitted with an intercurrent illness. Reference to the guidelines for the Management of Suspected Venous Thromboembolism and Treatment of Proven Venous Thromboembolism should also be considered if appropriate. 2. PATIENT SELECTION

• All medical inpatients should be assessed with respect to their risk of developing thrombosis and have the “VTE and Bleeding Risk Assessment” Proforma completed (Appendix 1)).

• This must be completed, signed and dated by the doctor admitting the patient.

• Medical staff are responsible for prescribing the GCS and LMWH where appropriate.

• Nursing staff on the ward are responsible for fitting the full length GCS and checking/re-fitting daily. Below knee stockings should only be used where patients are unable to tolerate full length or other circumstances exist which make above knee stockings ineffective or impractical.

• Medical and nursing staff should reinforce the importance of thromboprophylaxis, especially early mobilisation and good hydration.

• Nursing staff must ensure the patient has been provided with the Trusts leaflet on “Preventing Blood Clots in Hospital”

• Nursing staff on the wards must ensure every patient is given help and instruction on fitting the stockings; re-assessment and refitting should occur daily. Soiled stockings should be replaced immediately. Patients should be advised to wear appropriate footwear.

If LMWH is appropriate but there is a contra-indication then a sequential compression device should be considered (to be worn continuously, when patient not mobilising) for the same length of time that LMWH would have been given. Regular Risk Assessment Regular risk assessment is the cornerstone of identifying high risk patients. This must be done on admission for all patients using the Trust’s ‘VTE and bleeding risk assessment tool’ (appendix 1). The risk assessment tool helps the clinician balance the risks of bleeding and venous thrombosis. It should be used again at 24 hours after admission and regularly thereafter as this balance of risk can change on several occasions during a hospital spell. 3. PROCESS/RISK ASSESSMENT FOR IDENTIFYING PATIENTS AT RISK OF VENOUS THROMBOEMBOLISM Be guided by information on the risk assessment tool and ensure all appropriate interventions are completed and signed for; including

• Verbal and written information given to the patient • GCS, fitting and assistance • LMWH prescribed appropriately at 18:00

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• Sequential Compression device if LMWH contraindicated (stating contraindication to LMWH)

4. GRADUATED COMPRESSION STOCKINGS (GCS) It is vital that they are fitted properly and the patient wears them continuously. A member of staff trained in their use should give advice and help to all patients; showing how to wear them correctly. They should be checked by a person trained in their use at least daily and refitted / replaced as necessary. Where a contra-indication exists alternative methods of thromboprophylaxis should be considered. Full length GCS should be worn unless the patient is unable to comply with wearing them, when below knee GCS can be substituted. Contraindications to GCS; see below 5. LOW MOLECULAR WEIGHT HEPARIN (LMWH) At present the LMWH used as thromboprophylaxis within DGOH NHS Trust is Enoxaparin. The standard dose is 40mg subcutaneously given at 18:00 daily at least until discharge or patient considered low risk. 6. IF VTE SUSPECTED If VTE suspected, perform a wells (= or >2) criteria and a D-Dimer (= or >255) to assess probability. If either markers indicative, arrange a Doppler ultrasound to identify or exclude diagnosis. 7. CONTRAINDICATIONS Contra-indications to the use of either GCS or LMWH are unusual. It would be expected that the contraindication was agreed between nursing and medical staff and clear documentation is made on the proforma stating

1. Details of the contraindication and 2. What alternative method (if any) of thromboprophylaxis is deemed

appropriate Not all contraindications are fixed and it maybe after appropriate treatment and re-assessment it is possible to introduce GCS and/or LMWH. Contraindications LMWH: All patients who have any of the following

o Active bleeding o Acquired bleeding disorders (eg acute liver failure) with abnormal clotting

indices o Concurrent use of anticoagulants known to increase the risk of bleeding (such

as warfarin with INR > 2) o Lumbar puncture/epidural/spinal anaesthesia, neurosurgery or eye surgery

within the previous 4 hours or expected within the next 12 hours o Acute stroke o Thrombocytopenia (platelets < 75 x 10 /I) o Uncontrolled systolic hypertension (≥ 230/120 mmHg) o Untreated inherited bleeding disorders (such as haemophilia or von

Willebrand’s disease) o Known hypersensitivity to enoxaparin o Heparin Induced Thrombocytopenia (HIT) type 2 (Discuss with consultant

haematologist)

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Cautions: Renal Impairment (always seek advice of anticoagulation team),

hepatic insufficiency or increased bleeding potential. Renal failure: Patients with significant renal impairment or renal failure will accumulate LMWH and may need only occasional dosing.

Such patients should be discussed with a Consultant Haematologist and advice sort on frequency of dosing and monitoring.

Contraindications to GCS. o Acute Stroke o Suspected or proven peripheral arterial disease o Peripheral arterial bypass grafting o Peripheral neuropathy or other causes of sensory impairment o Leg ulceration/wounds or other conditions where stockings may cause/worsen

damage o Cardiac failure o Severe leg oedema of any cause o Major limb deformity or unusual leg size/shape preventing correct fit

8. AUDITING An audit will be performed on an annual basis to ensure a true record is kept to monitor compliance of VTE prevention. Originators: Dr Philip Brammer, Consultant Physician

Dr Julian Sonksen, Consultant Anaesthetist On behalf of the Thrombosis Committee

Approver: Dr Paul Harrison, Medical Director Date of Ratification: May 2010 Date of Review: May 2013 This Guideline supersedes the Guideline of the same name dated: December 2007 References 1. NICE clinical guideline 92 Venous Thromboembolism: reducing the risk. Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. NICE Jan 2010 2. Scottish Intercollegiate Guidelines Network (SIGN) Guideline No 62: Prophylaxis of Venous Thromboembolism. 2002. 3. Geerts WH, Pineo GF et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep; 126 (3 suppl): 338S-400S 4. The VERITY Steering Committee. The Third Venous Thromboembolism Registry Report. VERITY 2005 5. Nicolaides AN, Fareed J et al. Prevention and Treatment of Venous thromboembolism. International Consensus Statement (Guidelines according to scientific evidence). International Angiology 2006;25(2):101-61 6. Leizorovicz A, Mismetti P. Preventing Venous Thromboembolism in Medical Patients. Circulation 2004;110;13-19 7. Turpie A, Leizorovicz A. Prevention of venous thromboembolism in medically ill patients: a clinical update. Postgraduate Medical Journal 2006; 82; 806-8

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Operations Directorate:

Maternity and Children’s Service

Name of Guideline: REDUCING THE RISK OF VENOUS THROMBOEMBOLISM (VTE) DURING PREGNANCY AND IN PUERPERIUM Guideline No:

238

Author/Reviewed by:

Ms Uzma Zafar, Consultant Obstetrician & Gynaecologist

Version:

4

Ward/Department:

Maternity Unit

Replacing Document:

VTE and Thromboprophylaxis in pregnancy

Approving Committee:

Risk Management Group

Date Approved:

15th November 2010

Date for Review:

October 2013

Related Guidelines:

Aim of Guideline: To ensure women are appropriately assessed throughout pregnancy and to provide guidance on management when a risk has been identified.

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1. INTRODUCTION: Pulmonary embolism (PE) remains the leading direct cause of maternal death in the UK (1.56/100 000 maternities) and is the second most common cause of maternal deaths overall (11% of maternal deaths). Many PEs are preventable with appropriate thromboprophylaxis. NICE suggests that it is reasonable to assume that low molecular weight heparin (LMWH) may reduce the risk of VTE in obstetric patients by up to two-thirds. Approximately 80% of the women who died from PE in the UK between 2003 and 2005 had identifiable risk factors and (70%) from the UK Obstetric Surveillance System cohort of fatal and nonfatal antenatal PEs also had identifiable risk factors. Many antenatal VTE events occur in the first trimester and hence prophylaxis should begin early in pregnancy. However, the highest risk period is during the postpartum period. Both vaginal delivery and Caesarean section are risk factors for VTE. The overall Incidence of VTE in pregnancy and the puerperium is 1–2/1000. Overall case fatality for VTE in pregnancy is approximately 1%. As the absolute risk of VTE in pregnancy is low, risk assessment is needed to decide which women require thromboprophylaxis. The threshold for recommending postpartum thromboprophylaxis is lower because the risk/day is higher and the duration of risk is shorter.

2. RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) IN PREGNANCY AND PUERPERIUM

Pregnancy is associated with an increased risk of VTE. There are several other factors which can increase the risk of VTE. Women should have a risk assessment done for VTE at the following times in pregnancy (Appendix 1):

• Booking visit or early pregnancy • Antenatal admission • Following delivery.

(NB : Risk may need to be re-assessed at any stage if there is a change in the mother’s condition)

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RISK ASSESSMENT RISK FACTORS Pre-existing risk factors : Tick Score Thromboprophylaxis with LMWH should

be considered if : • Antenatal (outpatient) score 3 or

more - Refer to Haematologist • Antenatal (inpatient) score 1.5 or

more - Refer to obstetrician to prescribe

• Post-delivery : Score 2, LMWH for 7 days Score 3 or more, or already on LMWH antenatally, LMWH for 6 weeks

GECS (Graduated elastic compression stockings) should be given until fully mobile (unless contraindicated) after caesarean section or if score ≥ 3 following delivery If any identified bleeding risk (see below), the balance of risks between bleeding and clotting may need to be discussed with Obstetrician or Haematologist.

* Thrombophilia : Factor V Leiden / PT20210A / Protein C deficiency / Protein S deficiency Antiphospholipid Syndrome

Previous recurrent VTE 3 Previous VTE - unprovoked or pregnancy / oral contraceptive pill related

3

Previous VTE – provoked (e.g. post trauma / surgery)

2

Family history of VTE (in parent / sibling or in 2 other family members)

1

Known thrombophilia * Antithrombin deficiency

2 3

Medical conditions (e.g. SLE, inflammatory bowel disease, cardiac disease, nephrotic syndrome)

2

Age ≥ 35 years

0.5

Obesity : BMI > 30 BMI > 40

0.5 1

Parity ≥ 3 (previous pregnancies)

0.5

Smoker 0.5 Varicose veins with phlebitis 2 Current Obstetric risk factors :

Pre-eclampsia 1 Dehydration / hyperemesis / ovarian hyperstimulation

1

Multiple pregnancy 1

Caesarean section in labour 1.5

Elective caesarean section 1 Mid-cavity or rotational forceps

1

Prolonged labour (> 24 hours) 1

PPH (> 1 litre or requiring transfusion)

1

Transient risk factors :

Current systemic infection 1

Immobility 1

Surgical procedure in pregnancy or postpartum period

2

Bleeding risks - Known bleeding disorder - Active antenatal or postnatal bleeding - Women considered at risk of major haemorrhage - Platelet count < 75 - Acute stroke in previous 4 weeks - Severe renal disease (GFR < 30ml / min) or severe liver disease - Uncontrolled hypertension (>200 mmHg systolic or > 120 diastolic)

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2.1 Risk assessment process 2.1.1. Review risk factors for VTE on assessment sheet:

• at taking of booking history • on antenatal admission (except early labour / induction) • following delivery (before transfer to ward)

2.1.2. Document score, sign and date entry

2.1.3. Check no bleeding risks 2.1.4 If risk is identified discuss the significance of the signs and symptoms of

VTE and document this on the risk assessment form (Appendix 1).

2.2 Action to be taken if risk identified

• If the Antenatal (outpatient) score is 3 or more - Refer to Obstetrician to confirm risk and refer to the Haematologist

• Antenatal (inpatient) score 1.5 or more - Refer to obstetrician to prescribe thromboprophylaxis

• Post-delivery : o Score 2, LMWH for 7 days o Score 3 or more, or already on LMWH antenatally, LMWH for 6

weeks 2.3 Documentation Any woman requiring Thromboprophylaxis must have a management plan documented in the antenatal or postnatal notes. 3. SUGGESTED THROMBOPROPHYLACTIC DOSES FOR ANTENATAL LMWH 3.1 Weight (kg) Dalteparin

< 50 2500 units daily 50–90 5000 units daily 91–130 7500 units daily 131–170 10 000 units daily > 170 75 units/kg/day

3.2 Testing for thrombophilia in women with prior VTE Women with a previous non-estrogen-related VTE provoked by a minor risk factor should be offered thrombophilia testing. Results of thrombophilia screening should be interpreted with caution if undertaken during pregnancy. Testing for protein S is not reliable in pregnancy. 3.3 Management of women with asymptomatic thrombophilia Women with asymptomatic inherited thrombophilia without other risk factors should have close surveillance antenatally but prescribed LMWH for at least 7 days postpartum. Patients with antithrombin deficiency or more than one thrombophilic defect (including homozygous factor V Leiden, homozygous prothrombin G20210A and compound heterozygotes) or those with additional risk factors should be referred to the consultant haematologist.

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4. MANAGEMENT OF WOMEN WITH ACQUIRED THROMBOPHILIA (ANTIPHOSPHOLIPID SYNDROME): 4.1 Women with previous thromboses and antiphospholipid syndrome should be offered both antenatal and 6 weeks of postpartum thromboprophylaxis. 4.2 Women with persistent antiphospholipid antibodies and no previous VTE and no other risk factors or fetal indications for LMWH should have close surveillance antenatally but offered LMWH for 7 days postpartum after discussion with consultant haematologist. 5. WHEN SHOULD THROMBOPROPHYLAXIS BE STARTED Antenatal thromboprophylaxis should begin as early in pregnancy as practical. 6. THROMBOPROPHYLAXIS DURING LABOUR AND DELIVERY, INCLUDING THE USE OF REGIONAL ANAESTHESIA AND ANALGESIA 6.1 Women receiving antenatal LMWH should be advised that if they have any vaginal bleeding or once labour begins, they should not inject any further LMWH. They should be reassessed on admission to hospital and further doses should be prescribed by medical staff. 6.2 For women receiving high prophylactic or therapeutic doses of LMWH, the dose of heparin should be reduced to its thromboprophylactic dose on the day before induction of labour. 6.3 For elective caesarean section, the woman should receive a thromboprophylactic dose of LMWH on the day before delivery. On the day of delivery, any morning dose should be omitted and the operation should be performed that morning. The thromboprophylactic dose of LMWH should be given 4 hours post-operatively or 4 hours after removal of the epidural catheter 6.4 Regional anaesthetic techniques should not be used until at least 12 hours after the previous prophylactic dose of LMWH. If a woman presents while on a therapeutic regimen of LMWH, regional techniques should not be employed for at least 24 hours after the last dose of LMWH.1 6.5 LMWH should not be given for 4 hours after use of spinal anaesthesia or after the epidural catheter has been removed; the cannula should not be removed within 10–12 hours of the most recent injection. 7. POSTNATAL THROMBOPROPHYLAXIS 7.1 Postnatal risk assessment Refer to Table 1 for postnatal risk assessment. 7.2 Women who have additional persistent (lasting more than 7 days postpartum) risk factors, such as prolonged admission or wound infection, thromboprophylaxis should be extended for up to 6 weeks or until the additional risk factors are no longer present.

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8. AGENTS TO BE USED FOR THROMBOPROPHYLAXIS 8.1 LMWHs are the agents of choice for antenatal thromboprophylaxis. They are at least as effective as and safer than unfractionated heparin. In our trust, Dalteparin is used for antenatal thromboprophylaxis and continued in the postnatal period. For routine thromboprophylaxis post delivery, Enoxaparin is used (40mg) and please refer to Appendix 2 for weight related doses. 8.2 Unfractionated heparin may be used around the time of delivery in women at very high risk of thrombosis (when there may be reluctance to use LMWH in case regional anaesthetic techniques are required) or in women at increased risk of haemorrhage. It should be prescribed only in consultation with consultant haematologist. 8.3 Warfarin Warfarin is only used in pregnancy where heparin is considered unsuitable; for example, patients with mechanical heart valves. Warfarin can cause congenital abnormalities including warfarin embryopathy in approximately 5% of fetuses exposed between 6 and 12 weeks of gestation, Other complications associated with warfarin therapy during pregnancy include an increase in the risk of spontaneous miscarriage, stillbirth, neurological problems in the baby and fetal and maternal haemorrhage. Warfarin is appropriate for postpartum thromboprophylaxis if women are receiving long term anticoagulation with warfarin, this can be started usually 5–7 days after delivery. Both warfarin and LMWH are safe when breastfeeding. 9. GRADUATED ELASTIC COMPRESSION STOCKINGS: All women with previous VTE or a thrombophilia should be offered to wear graduated compression stockings throughout their pregnancy and for 6–12 weeks after delivery. GECS is recommended for women after caesarean section and antenatally and postpartum for all women with a previous DVT. 9.1 Indications of GECS:

• those who are hospitalised and have a contraindication to LMWH • those who are hospitalised post-caesarean section (combined with LMWH)

and considered to be at particularly high risk of VTE (score >3) • outpatients with prior VTE (usually combined with LMWH) • women travelling long distance for more than 4 hours.

10. AUDITABLE STANDARDS Implementation of this guideline will be audited annually and is included in the Maternity Audit Programme. 1% of health records will be audited from all women who have received thromboprophylaxis in the antenatal and postnatal period. The audit criteria will as a minimum, monitor the implementation of the following standards and subject to a multidisciplinary review

• Appropriate and timely risk assessments to identify those at risk of VTE • The significance of signs and symptoms in light of known risk factors

Page 7 of 13

• The actions to be taken in response to risk assessments once the risk of VTE has been identified

• The requirement to document an individual management plan for women who require thromboprophylaxis

• Thromboprophylaxis during pregnancy • The care during labour and delivery of women on thromboprophylaxis • Thromboprophylaxis during the postnatal period

It is expected that there is 100% compliance with this guideline. 11. MONITORING

When the audit has identified deficiencies (less than 100% compliance) the action will be reviewed in the named forum and progress monitored through the Guidelines and Policies Group on a 6 monthly basis to ensure that changes are implemented within the identified forum. 12. REFERENCES: Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines (8th edition). Chest 2008;(6 Suppl):844S–6S. DOI: 10.1378/chest.08-0761. [www.chestjournal.org/cgi/content/abstract/133/6_suppl/844S]. Bauersachs RM, Dudenhausen J, Faridi A, Fischer T, Fung S, Geisen U, et al. Risk stratification and heparin prophylaxis to prevent venous thromboembolism in pregnant women. Thromb Haemost 2007;98:1237–45.

Monitoring Forum responsible Frequency The audit will include as a minimum:

• Appropriate and timely risk assessments to identify those at risk of VTE

• The significance of signs and symptoms in light of known risk factors

• The actions to be taken in response to risk assessments once the risk of VTE has been identified

• The requirement to document an individual management plan for women who require thromboprophylaxis

• Thromboprophylaxis during pregnancy

• The care during labour and delivery of women on thromboprophylaxis

• Thromboprophylaxis during the postnatal period

Audit Thrombosis committee Annually

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Blanco-Molina A, Trujillo-Santos J, Criado J, Lopez L, Lecumberri R, Gutierrez R, Monreal M; RIETE Investigators. Venous thromboembolism during pregnancy or postpartum: findings from the RIETE Registry. Thromb Haemost 2007;97:186–90. Born D, Martinez EE, Almeida PA, Santos DV, Carvalho AC, Moron AF, et al. Pregnancy in patients with prosthetic heart valves: the effects of anticoagulation on mother, fetus, and neonate. Am Heart J 1992;124:413–17. Chong MK, Harvey D, de Swiet M. Follow-up study of children whose mothers were treated with warfarin during pregnancy. Br J Obstet Gynaecol 1984;91:1070–3. Confidential Enquiry into Maternal and Child Health. Saving Mothers’ Lives: Reviewing Maternal Deaths to Make Motherhood Safer, 2003–2005. The Seventh Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. London: CEMACH; 2007 [www.cmace.org.uk/Publications/CEMACHPublications/Maternal-and-Perinatal-Health.aspx]. Cotrufo M, De Feo M, De Santo LS, Romano G, Della Corte A,Renzulli A, et al. Risk of warfarin during pregnancy with mechanical valve prostheses. Obstet Gynecol 2002;99:35–40. Ensom MHH, Stephenson MDD. Low-molecular-weight heparins in pregnancy. Effects 2008;(2). Gherman RB, Goodwin TM, Leung B, Byrne JD, Hethumumi R, Montoro M. Incidence, clinical characteristics, and timing of objectively diagnosed venous thromboembolism during pregnancy. Obstet Gynecol 1999;94:730–4. Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood 2005;106:401–7. Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ 3rd. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med 2005;143:697–706. Holzgreve W, Carey JC, Hall BD. Warfarin-induced fetal abnormalities. Lancet 1976;2:914–15. Horlocker TT, Wedel DJ, Benzon H, Brown DL, Enneking FK, Heit JA, et al. Regional anesthesia in the anticoagulated patient:defining the risks (the second ASRA Consensus Conference on Neuraxial Anesthesia and Anticoagulation). Reg Anesth Pain Med 2003;28:172–97. Jacobsen AF, Skjeldestad FE, Sandset PM. Ante- and postnatal risk factors of venous thrombosis: a hospital-based case–control study. J Thromb Haemost 2008;6:905–12. James AH, Tapson VF, Goldhaber SZ. Thrombosis during pregnancy and the postpartum period. Am J Obstet Gynecol 2005;193:216–19.

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James AH. Prevention and management of venous thromboembolism in pregnancy. Am J Med 2007;120:S26–34. Khamooshi AJ, Kashfi F, Hoseini S, Tabatabaei MB, Javadpour H, Noohi F. Anticoagulation for prosthetic heart valves in pregnancy: is there an answer? Asian Cardiovasc Thorac Ann 2007;15:493–6. Knight M, on behalf of UKOSS. Antenatal pulmonary embolism: risk factors, management and outcomes. BJOG 2008;115:453–61. Lindqvist P, Dahlbäck B, Marŝál K. Thrombotic risk during pregnancy: a population study. Obstet Gynecol 1999;94:595–9. Liu S, Liston RM, Joseph KS, Heaman M, Sauve R, Kramer MS, et al. Maternal mortality and severe morbidity associated with low-risk planned cesarean delivery versus planned vaginal delivery at term. CMAJ 2007;176:455–60. Nassar AH, Hobeika EM, Abd Essamad HM, Taher A, Khalil AM, Usta IM. Pregnancy outcome in women with prosthetic heart valves. Am J Obstet Gynecol 2004;191:1009–13.

Nice (2010) Clinical Guideline CG92. Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital

Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost 2008;6:632–7. Royal College of Obstetricians and Gynaecologists. Air Travel and Pregnancy. Scientific Advisory Committee Opinion Paper No. 1. London: RCOG; 2008 [www.rcog.org.uk/womenshealth/clinical-guidance/air-travel-and-pregnancy]. RCOG guideline (2009) Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk (Green-top 37) Sanson BJ, Lensing AWA, Prins MH, Ginsberg JS, Barkagan ZS, Lavenne-Pardonge E, et al. Safety of low-molecular-weight heparin in pregnancy: a systematic review. Thromb Haemost 1999;81:668–72. Sareli P, England MJ, Berk MR, Marcus RH, Epstein M, Driscoll J, et al. Maternal and fetal sequelae of anticoagulation during pregnancy in patients with mechanical heart valve prosthesis. Am J Cardiol 1989;63:1462–5. Sbarouni E, Oakley CM. Outcome of pregnancy in women with valve prostheses. Br Heart J 1994;71:196–201. Schaefer C, Hannemann D, Meister R, Eléfant E, Paulus W, Vial T, et al. Vitamin K antagonists and pregnancy outcome. A multicentre prospective study. Thromb Haemost 2006;95:949–57.

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Vitale N, De Feo M, De Santo LS, Pollice A, Tedesco N, Cotrufo M. Dose-dependent fetal complications of warfarin in pregnant women with mechanical heart valves. J Am Coll Cardiol 1999;33:1637–41. Walker ID, Greaves M, Preston FE. British Society for Haematology Guideline. Investigation and management of heritable thrombophilia. Br J Haematol 2001;114:512–28. Wesseling J, Van Driel D, Heymans HS, Rosendaal FR, Geven-Boere LM, Smrkovsky M, et al. Coumarins during pregnancy:long-term effects on growth and development of school-age children. Thromb Haemost 2001;85:609–13

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APPENDIX 1 VTE PROFORMA RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE) IN OBSTETRIC PATIENTS Risk assessment should be performed at:

• Booking • Every admission to hospital • Immediate postpartum

Thrombosis Risk: (enter and date of assessement in relevant box) PRE-EXISTING RISK FACTORS Score DATE DATE DATE Known Thrombophilia Antithrombin deficiency

2 3

Family history of VTE 1 Previous provoked VTE (trauma/surgery)

2

BMI > 30 BMI >40

0.5 1

Parity > 3 0.5 Gross varicose veins with phlebitis 2 Age ≥ 35

0.5

Medical conditions (e.g SLE, IBD,ephritic syndrome, cardiac diseases, cancer)

2

Recurrent VTE or Previous unprovoked VTE, or secondary to OC pill/pregnancy

3

IV drug user 2 Smoker 0.5 TRANSIENT RISK FACTORS Severe acute infections 1 Surgical procedures A/N or P/N 2 Dehydration/hyperemesis/OHSS 1 Moderate or severe pre-eclampsia 1 Midcavity instrumental delivery 1 Massive obstetric haemorrhage APH/PPH

1

Prolonged labour( > 24 hours) 1 Immobility > 4days Antenatal A/N, any immobility Postnatal P/N,SPD

1

Elective caesarean section 1 Emergency caesarean 1.5 Multiple pregnancy 1 Thromboprophylaxis with LMWH should be considered if :

• Antenatal (outpatient) score 3 or more Refer to Haematologist • Antenatal (inpatient) score 1.5 or more Refer to obstetrician to prescribe • Post-delivery :

Score 2, usually LMWH for 7 days Score 3 or more, or already on LMWH antenatally, continue LMWH for 6 weeks postnatally

GECS (TED Stockings) should be given until fully mobile (unless contraindicated) after caesarean section, or if score ≥ 3 following delivery

Affix label OR enter details NAME: HOSPITAL NO: DOB:

Page 12 of 13

Risk assessment process • Review risk factors for VTE on assessment sheet :

- at taking of booking history - on antenatal admission (except early labour / induction) - following delivery (before transfer to ward)

• Document score, sign and date entry • Check no bleeding risks • Refer to obstetrician to consider / prescribe LMWH if score indicates need for

treatment (see over). If further input is needed, the obstetrician can refer to the Consultant Haematologist

Guidance on thromboprophylactic doses for antenatal LMWH

Weight (kg) Dalteparin < 50 2500 units daily 50–90 5000 units daily 91–130 7500 units daily 131–170 10 000 units daily > 170 75 units/kg/day

Guidance on thromboprophylactic doses for postnatal LMWH If assessed as high risk in the postnatal period Enoxaparin to be prescribed Please refer to Appendix 2 for doses according to weight. Bleeding risks include:

• Known bleeding disorder (e.g. Haemophilia / von Willebrands disease) • Active antenatal or postnatal bleeding • Women considered at risk of major haemorrhage (e.g. placenta praevia) • Platelet count < 75 • Acute stroke in previous 4 weeks • Severe renal or liver disease • Uncontrolled hypertension (>200mmHg systolic or >120mmHg diastolic)

Risk assessment & treatment prescribed

Date assessed: Information given:

Yes No

(to be completed at time of risk assessment) Verbal consent obtained for initiation of thromboprophylaxis:

NA Yes No Treatment prescribed: NA Yes No If no treatment prescribed, was referral undertaken: Yes No

Risk assessed by:

Signature Name and Initials

RCOG guideline (2009) Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk (Green-top 37)

(Print name and initial)

Page 13 of 13

APPENDIX 2 SUGGESTED THROMBOPROPHYLACTIC DOSES FOR POSTNATAL LMWH Weight Dosage 50-90 kg

40mg Enoxaparin

91-130 kg 60 mg Enoxaparin

131-170kg 80 mg Enoxaparin

>170 kg 0.6 mg/kg/day Enoxaparin

Trust Headquarters Russells Hall Hospital

Dudley West Midlands

DY1 2HQ

Date: 03/10/2013

FREEDOM OF INFORMATION ACT 2000 - Ref: FOI/011587

With reference to your FOI request that was received on 04/09/2013 in connection with ' VTE prevention policies'.

Your request for information has now been considered and the information requested is attached.

Further information about your rights is also available from the Information Commissioner at: Information Commissioner Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF Tel: 0303 123 1113 Fax: 01625 524510 www.ico.gov.uk Yours sincerely Information Governance Manager