The evidence for the use of recombinant factor VIIa in massive bleeding: revision of the transfusion policy framework.
In 2006, the Canadian National Advisory Committee on Blood and Blood Products (NAC) developed a transfusion policy framework for the use of off-label recombinant factor VIIa (rFVIIa) in massive bleeding. Because the number of randomised controlled trials has doubled, the NAC undertook a review of the policy framework in 2011. On the basis of the review of 29 randomised controlled trials, there remains little evidence to support the routine use of rFVIIa in massive bleeding. Mortality benefits have not been demonstrated. Contrarily, an increase in arterial thromboembolic events has been observed with the use of off-label rFVIIa. Given the absence of evidence of benefit and with evidence of the risk of harm, the NAC recommends that recombinant VIIa no longer be used for the off-label indications of prevention and treatment of bleeding in patients without haemophilia.
Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Ontario, Canada. yulia.lin@sunnybrook.ca
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Y
Lin
C J
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Moltzan
D R
DR
Anderson
D015942:Factor VIIa / Q000009:adverse effects* / Q000627:therapeutic use*; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D056687:Off-Label Use; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa