Key result
rFVIIa significantly reversed warfarin effects on thromboelastography parameters (P<.05) but did not improve bleeding duration or blood loss compared with placebo in healthy subjects.
Why the study?
Does rFVIIa reduce bleeding duration and blood loss in healthy subjects treated with warfarin?
Population
97 healthy subjects subjected to warfarin treatment and a punch biopsy-induced bleeding model
Comparison
Recombinant activated factor VII 5-80 microg/kg vs Placebo
Design
RCT, randomized, double-blinded
Authors
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rFVIIa does not reduce bleeding despite TEG reversal in warfarin-treated subjects; challenges reliance on coagulation assays as surrogates for clinical efficacy.
RCT (n=97)
Double-blind
Randomized
No
Does rFVIIa reduce bleeding duration and blood loss in healthy subjects treated with warfarin?
p-value: p=<.05
In healthy subjects, rFVIIa reversed warfarin-induced changes in coagulation assays but failed to improve bleeding duration or blood loss in a punch biopsy model.
Skolnick et al. (2010) conducted an RCT in Healthy subjects (n=97). Recombinant activated factor VII (rFVIIa) vs. Placebo was evaluated on Bleeding duration, blood loss, coagulation parameters, and safety (p=<.05). rFVIIa significantly reversed warfarin effects on thromboelastography parameters (P<.05) but did not improve bleeding duration or blood loss compared with placebo in healthy subjects.
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