FIBRIN
OGEN
CONCENTRAT
E
DA
N H
YD
E 2
01
3
TAKE HOME POINTS
1.Fibrinogen deficiency can be congenital or acquired
2.Fibrinogen concentrate is licensed for use in the bleeding patient with congenital deficiency
3.Limited evidence for FC in acquired deficiency
4.Dose 70mg/kg if unknown level of fibrinogen
5.Aim for 1 to 1.5g/L
Dimer consisting of 3 pairs of polypeptide chains
Activated by thrombin and F8 to form fibrin and stabilize clot
Plasma levels 2.5-4g/L
FIBRINOGEN
Sourced from pooled human plasma
Purified and sterilized
100ml vial white powder lyophilized fibrinogen 1g
Reconstitute 50ml water (20mg/ml)
5yr storage 2-25 degrees
FIBRINOGEN CONCENTRATE
FIBRINOGEN DEFICIENCY/DYSFUNCTION
1. Congenital fibrinogen deficiencyAfibrinogenaemiaHypofibrinogenaemiaDysfibrinogaemia
2. Acquired fibrinogenaemiaConsumption (especially obstetric)DICLeukaemiaSevere hepatic dysfunction
FIBRINOGEN CONCENTRATE V CRYOPRECIPITATE- potential for virus transmission on screened but not
virally inactivated plasma
- volume overload for adequate fibrinogen replacement
- unnecessary protein infused (such as factor VIII/VWF in cryoprecipitate) that might contribute to thrombosis
- requirement for a blood bank and blood grouping of recipient
- potential allergic reactions and transfusion-related lung injury from plasma products.
INDICATIONS
Licensed use
Patients with congenital deficiency with spontaneous or post operative bleeding
Potential off-license use
Patients with dysfibrinogenaemia and bleeding (limited evidence)
Massive haemorrhage
Obstetric haemorrhage
Bleeding in cardiac surgery
EVIDENCE
All small mainly retrospective studies recommending larger, prospective trials
Fenger + Eriksen 2008
audit of massive haemorrhage patients over 2yrs
43 patient received FC
decreased PRBC rate and improved PT/APTT post adminstration
Rahe + Meyer 2009
retrospective review of blood product use in patients having AVR and ascending aorta replacement
transfusion algorithm for FFP and PLT products used by hospital
Those receiving FC before FFP/PLT had reduced PRBC requirement
EVIDENCE
Mercier + Bonnet 2010
literature review of obstetric haemorrhage
recommend FC be administered if fibrinogen levels remain less than 1-1.5g/L after FFP/CRYO administration
Dose
70mg/kg if unknown level
(target-measured)/0.017
in g/L
Target 1g/L for minor haemorrhage
Target 1.5g/L for major haemorrhage
Half life 78hrs
Cmax 1.3-1.4g/L
Slow IV infusion
Less than 5ml/min
ADMINSTRATION
ADVERSE EFFECTS
Potential allergy
Thrombosis
Infection transmission
screened for HIV/HBV/HCV/HAV
risk mainly for non-enveloped viruses (ie. Parvovirus)
TAKE HOME POINTS
1.Fibrinogen deficiency can be congenital or acquired
2.Fibrinogen concentrate is licensed for use in the bleeding patient with congenital deficiency
3.Limited evidence for FC in acquired deficiency
4.Dose 70mg/kg if unknown level of fibrinogen
5.Aim for 1 to 1.5g/L
RESOURCES
AETNA- clinical policy Bulletin
RiaStrap- product information
TGA- Australian Public Assessment Report- Human Fibrinogen