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Evidence summaries: RBC transfusion triggers
✓ Acute interventions – intensive care (7 PICO’s) (Cécile Aubron & Jerrold Levy)
✓ Critically ill intensive care patients✓ Septic shock✓ Orthopaedic and (non-)cardiac surgery✓ Cardiac surgery✓ Coronary heart disease✓ Acute gastrointestinal bleeding✓ Acute bleeding
✓ Haematology & Oncology (2 PICO’s) (Richard Gammon)✓ Neurology (2 PICO’s) (Cynthia So-Osman)
✓ Acute CNS injury✓ Cerebral perfusion disorders
Thank you to the presenters!
PICO questions
Should more restrictive RBC transfusion triggers (Intervention) versus more liberalRBC transfusion triggers (Comparison) be used in- Critically ill, but clinically stable intensive care patients (adults)? (Population 1)- Adult patients with septic shock? (Population 2) (COMBINED)
- Adult patients with orthopaedic and non-cardiac surgery? (Population 3)- Adult patients with coronary heart disease? (Population 4)- Adult patients with cardiac surgery? (Population 5)
- Adult patients with acute (gastrointestinal) bleeding? (Population 6/7)
- Adult patients with haematological diseases? (Population 8)- Adult patients with solid tumours? (Population 9)
- Adult patients with acute central nervous system injury? (Population 10)- Adult patients with cerebral perfusion disorders? (Population 11)
Outcomes of interest: clinical outcomes: mortality, morbidity-related outcomes that occured during hospitalisation, RBC utilisation
For each PICO:
• 30-day mortality as a critical outcome
• Draft recommendation
• Justification
• Relevant panel discussion points
• Audience vote on proposed recommendation
CRITERIA JUDGEMENTRESEARCH
EVIDENCEADDITIONAL CONSIDERATIONS
1. DESIRABLE EFFECTSHow substantial are the desirable anticipated
effects?
2. UNDESIRABLE
EFFECTS
How substantial are the undesirable
anticipated effects?
3. CERTAINTY OF
EVIDENCE
What is the overall quality of the evidence of
effects?
4 (5). VALUES
Is there important uncertainty about or
variability in how much people value the
critical outcomes?
5. BALANCE OF
EFFECTS
Does the balance between desirable and
undesirable effects favor the intervention or
the comparison?
6. RESOURCES
REQUIRED
How large are the resource requirements
(costs)?
7. COST
EFFECTIVENESS
Does the cost-effectiveness of the intervention
favor the intervention or the comparison?
8. EQUITY What would be the impact on health equity?
9. ACCEPTABILITYIs the intervention acceptable to key
stakeholders?
10. FEASIBILITY Is the intervention feasible to implement?
Evidence-to-Decision framework
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Audience
Haematology and oncology Should more restrictive RBC transfusion triggers (Intervention) versus
more liberal RBC transfusion triggers (Comparison) be used in
- Adult patients with haematological diseases? (Population 8)
- Adult patients with solid tumours? (Population 9)
HaematologyCRITICAL OUTCOME: 30-day mortality
Haematology (PICO 10)
No Hb trigger recommendation
Plus: The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger in haematology patients (including non-malignant conditions) (Y/N)
Justification: Insufficient evidence (two pilot studies in acute leukaemia, total 149 patients). No signal for undesirable effects.
Notes: Hb trigger in the two included trials was 7-8g/dL
Oncology (PICO 11)
No recommendation for Hb trigger (Y/N)
The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger in oncology patients (Y/N)
Justification: No evidence
Notes: Only available study was in post-op surgical oncology setting in ICU – considered in surgical (PICO 5)
CNS injury
Should more restrictive RBC transfusion triggers (Intervention)versus more liberal RBC transfusion triggers (Comparison) be
used in adult patients with acute central nervous system injury? (Population 10)
McIntyre et al (2006)
CRITICAL OUTCOME: 30-day mortality
Central nervous system injury (PICO 12)
No Hb trigger recommendation (Y/N)
Plus: The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger in patients with CNS injury (Y/N)
Justification: Very low level of evidence for all outcomes
Notes: Post hoc analysis of TRICC study (67 patients, randomised to Hb trigger of 7 or 10g/dL). No undesirable effects observed
Cerebral perfusion disorders
Should more restrictive RBC transfusion triggers (Intervention)versus more liberal RBC transfusion triggers (Comparison) be
used in adult patients with cerebral perfusion disorders? (Population 11)
Naidech et al (2010)No mortality data available CRITICAL OUTCOME: any adverse event related to transfusion
CRITICAL OUTCOME: pulmonary edema or respiratory distress
Cerebral perfusion disorders (PICO 13)
Recommendations: No Hb trigger recommendation (Y/N)The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger in patients with cerebral perfusion disorders (Y/N)
Justification: No evidence for any outcomes related to restrictive transfusion strategy because participants randomised to Hb trigger of 10 or 11.5 g/dL. Not considered a restrictive strategy.
Notes: One study of 44 patients with subarachnoid haemorrhage No undesirable effects observed.
Coronary heart diseaseShould more restrictive RBC transfusion triggers (Intervention) versus more liberal RBC transfusion triggers (Comparison) be used in adult
patients with coronary heart disease? (Population 4)
Coronary heart disease CRITICAL OUTCOME: 30-day mortality
CRITICAL OUTCOME: myocardial infarction
Coronary heart disease (PICO 7)
Recommendation: The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger in patients with acute coronary syndromes (Y/N)
Justification: There is an overall low level of evidence, and concern regarding undesirable effects with a restrictive strategy
Note: A conditional recommendation for either strategy cannot be made because of the concern over the possibility for undesirable effects in the restrictive group
Critical care
Should more restrictive RBC transfusion triggers (Intervention) versus more liberal RBC transfusion triggers (Comparison) be
used in adult critically ill, but clinically stable intensive care patients? (Population 1) including adult patients with septic
shock? (Population 2)
Critically ill and septic shockCRITICAL OUTCOME: 30-DAY MORTALITY
Critical care (PICO 4)
Strong recommendation (Y/N)• The ICC-PBM guideline panel recommends a transfusion trigger of 7 g/dL for treatment of anaemia in
critically ill patients who are not actively bleeding. (strong recommendation, moderate certainty)• This recommendation may not apply to patients with acute coronary syndromes and CNS injury/cerebral
perfusion disorders.• The ICC-PBM guideline panel suggests further research in these areas.
Justification: No evidence of increased mortality or other undesirable effects, and substantial reduction in red cell exposure and utilisation.
Notes: • Critical care population highly heterogeneous (reason for qualification)• Includes septic shock (originally separate PICO question 8)• Hb 7g/dL trigger represents the value used in the included trials• Panel had extensive discussion on whether the “may not apply” should include patients with a history of
coronary artery disease/other cardiovascular disease
Cardiac surgery
Should more restrictive RBC transfusion triggers (Intervention)versus more liberal RBC transfusion triggers (Comparison) be
used in adult patients undergoing cardiac surgery? (Population 5)
Cardiac surgery
CRITICAL OUTCOME: 30-day mortality
Strong recommendation:The ICC-PBM guideline panel recommends using a transfusion trigger of Hb <7.5 g/dL in cardiac surgery patients, based on moderate certainty in the evidence of effects. (Y/N)
(Strong recommendation, moderate level of evidence)
Justification: No evidence of increased mortality or other undesirable effects, and substantial reduction in red cell exposure and utilisation.
Note: 7.5g/dL trigger represents the value used in the included trials
Cardiac surgery (PICO 9)
Orthopaedic surgeryShould more restrictive RBC transfusion triggers (Intervention) versus more liberal RBC transfusion triggers (Comparison) be used in adult
patients undergoing orthopaedic surgery? (Population 3)
Orthopaedic surgeryCRITICAL OUTCOME: 30-day mortality
CRITICAL OUTCOME: myocardial infarction
Orthopaedic surgery (PICO 5)
Conditional recommendation (Y/N)The ICC-PBM guideline panel suggest using a transfusion trigger (Hb <8 g/dL) in elderly patients with hip fracture
(weak recommendation, moderate evidence)
Justification: No effect on mortality (although wide CI) or functional outcomes (walk independently at 60days). However, uncertainty regarding undesirable effects, in particular AMI. Therefore weak recommendation.
Notes: • Hb 8g/dL trigger represents the value used in the included trials• Can we extrapolate trial data in hip fracture to elderly patients undergoing
other orthopaedic surgery? And all patients undergoing other orthopaedic surgery? And other non-ortho, non-cardiac surgery?
• Major evidence gaps in these areas - research recommendation to be made
Other surgery
Non-orthopaedic & non-cardiac surgery
CRITICAL OUTCOME: 30-day mortality
Note: vascular surgery not discussed by panel due to insufficient time
Other surgery (non-ortho, non-cardiac, PICO 5 cont’d)
Recommendation: The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger in other surgical populations (Y/N)
Justification: There is an overall low level of evidence, and concern in surgical oncology patient regarding undesirable effects with a restrictive strategy
Note: A conditional recommendation for either strategy cannot be made because of the concern over the possibility for undesirable effects in the restrictive group
Acute upper GI bleedingShould more restrictive RBC transfusion triggers
(Intervention) versus more liberal RBC transfusion triggers (Comparison) be used in adult patients with acute (gastrointestinal) bleeding? (Population 6/7)
Acute (gastrointestinal) bleeding
CRITICAL OUTCOME: 30-DAY MORTALITY
Acute GI bleeding (PICO 6)
Conditional recommendation (Y/N): The ICC-PBM guideline panel suggest transfusion trigger of Hb 7-8g/dL in patients with acute upper GI bleeding who are haemodynamically stable (or “who are not exsanguinating”?)(weak recommendation, low level of evidence)
The ICC-PBM guideline panel decided to formulate a recommendation for further research on the use of restrictive transfusion trigger acute GI bleeding (Y/N)
Justification: Two trials, both excluded exsanguinating patients. Lower mortality with restrictive strategy. No evidence of undesirable effects. Reduction in RBC exposure and utilisation. Notes: • PICO was “acute GI bleeding”. Recommendations limited to acute upper GI bleeding.• “Massive exsanguinating” patients excluded from the trials. No trials identified in
lower GI bleeding.• Guidelines should emphasise that in the acutely bleeding patient, Hb is not the
deciding factor for transfusion.• Trials used Hb triggers (e.g. Hb 7) to achieve specified Hb target ranges (e.g. Hb 7-9).
Acute bleeding (PICO 14)No recommendation for Hb trigger
The ICC-PBM guideline panel does not recommend research on the use of Hb triggers for transfusion in patients with major bleeding (exsanguinating patients) (Y/N)
Justification: No evidence. One pseudo-randomised trial from 1956 identified.
Notes: • Panel view is that a Hb concentration alone should not be used to determine
the need for transfusion in an acutely bleeding (i.e. major haemorrhage) scenario. Recommend refer to existing massive transfusion/major haemorrhage protocols/guidelines)
• ICC PBM Guidelines should emphasise that in the acutely bleeding patient, Hb is not the deciding factor for transfusion.
Question and discussion