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