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Low-dose recombinant factor VIIa for massive bleeding: a single centre observational cohort study with 73 patients
Pirmin Schmid1, Andrea Mordasini, Martin Luginbühl
1Department of Hematology and Central Hematology Laboratory, Inselspital, University Hospital and University of Bern, Switzerland.
Swiss Medical Weekly
|July 8, 2011
Summary
Low-dose recombinant activated factor VII (rFVIIa) effectively controlled massive bleeding in patients. This study found a 60 μg/kg dose to be safe and efficacious, reducing bleeding and transfusion needs with minimal complications.
Area of Science:
- Critical Care Medicine
- Hematology
- Pharmacology
Background:
- Recombinant activated factor VII (rFVIIa) is used off-label for massive bleeding, but evidence of benefit and optimal dosage is lacking.
- The minimal effective dose for rFVIIa in massive hemorrhage remains unknown, necessitating further investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of an in-house guideline recommending a low dose of 60 μg/kg for off-label rFVIIa use in massive bleeding.
- To assess the impact of low-dose rFVIIa on bleeding rates, transfusion requirements, and patient survival.
Main Methods:
- An observational cohort study was conducted at a tertiary care university hospital.
- Seventy-three patients with massive bleeding treated off-label with rFVIIa between 2005 and 2007 were analyzed.
- Outcomes assessed included survival, bleeding rates, transfusion volumes, coagulation parameters, and complications.
Main Results:
- The median rFVIIa dose administered was 64 μg/kg, with 79% receiving a single dose.
- Significant reductions were observed in bleeding rates (82% reduction) and transfusion requirements for red blood cells, platelets, and fresh frozen plasma.
- In-hospital mortality was 14% within 24 hours and 32% at 30 days, with two possibly related arterial thromboembolic complications.
Conclusions:
- A single 60 μg/kg dose of rFVIIa appears efficacious in controlling massive bleeding.
- This lower-than-usual dose demonstrated a very low complication rate.
- The findings support the use of low-dose rFVIIa as a potentially effective strategy for managing massive hemorrhage.
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