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Recombinant activated factor VII: does it really save lives?
Critical Care volume 13, Article number: P429 (2009)
At pharmacological doses, recombinant activated factor VII (rFVIIa) bypasses conventional steps in coagulation cascade and directly generates a thrombin burst on the activated platelets at the injury, leading to the generation of fully stabilized tight fibrin clot.
Using the experience of our institute and an Internet search. In one of the largest prospective, randomized, multicentric studies of rFVIIa, 301 patients with blunt/penetrating trauma were enrolled – of whom 277 patients at the end of study were analyzable. The trial included 399 patients, all diagnosed by CT scan within 3 hours of intracerebral hemorrhage onset. Patients were randomly assigned to receive placebo (n = 96), 40 μg/kg (n = 108), 80 μg/kg (n = 92), or 160 μg/kg (n = 103) doses of rFVIIa within 1 hour of the baseline scan. The results of the Survival of Myocardial Infarction Long-Term Evaluation study (that is, the largest controlled study showing the relationship between genetic polymorphisms and disease) demonstrated that propensity to high factor VII levels is not associated with a risk for myocardial infarction.
One study has demonstrated that one single dose of rFVIIa (80 μg/kg) could reduce transfusion requirements in cirrhotic patients undergoing orthotopic liver transplant. Compared with 29% growth in the placebo arm, intracerebral hemorrhage volume growth in the 40, 80, and 160 μg/kg arms was 16%, 14%, and 11%, respectively (corresponding to a relative reduction of 45%, 52% and 62%).
Use of rFVIIa should be reserved for salvageable patients with coagulopathic bleeding that is unresponsive to existing medical therapies. Definitive surgical control of accessible sites of hemorrhage is nevertheless a necessary intervention.
Hendriks HG, Meijer K, et al.: Reduced transfusion requirements by rFVIIa in orthotopic liver transplantation. Transplantation 2001, 71: 402-405. 10.1097/00007890-200102150-00011
Mayer SA, Brun NC, et al.: rFVIIa for acute intracerebral hemorrhage. N Engl J Med 2005, 352: 777-785. 10.1056/NEJMoa042991
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Edke, U. Recombinant activated factor VII: does it really save lives?. Crit Care 13, P429 (2009). https://doi.org/10.1186/cc7593
- Intracerebral Hemorrhage
- Orthotopic Liver Transplant
- Fibrin Clot
- Hemorrhage Volume