MedWire News: Recombinant activated factor VII (rFVIIa) may be beneficial for treating bleeding after cardiac surgery, preliminary research suggests.
“For the first time a hemostatic agent has the possibility of being an effective alternative to allogeneic transfusion in cardiac surgery patients with uncontrolled postoperative bleeding,” say Ravi Gill (Southampton University Hospitals, UK) and colleagues.
However, they still advise caution when using rFVIIa after finding it increased the number of critical serious adverse events, including stroke, compared with placebo.
For their phase II dose-escalation study, the researchers randomly assigned 172 patients who had undergone cardiac surgery and were bleeding to receive placebo, 40 µg/kg rFVIIa, or 80 µg/kg rFVIIa.
They found that significantly fewer patients receiving rFVIIa needed a re-operation as a result of bleeding, at 14% of those given 40 µg/kg rFVIIa and 12% of those given 80 µg/kg rFVIIa compared with 25% of patients given placebo.
Patients receiving rFVIIa also required smaller allogeneic blood transfusion volumes, at an average of 640 mL and 500 mL for those given 40 µg/kg and 80 µg/kg of the drug, respectively, compared with 825 mL for those given placebo.
The proportion of patients avoiding blood transfusions was also higher among those given rFVIIa compared with placebo.
In all, 18 critical serious adverse events occurred; 13 in patients receiving rFVIIa and five in those receiving placebo.
This difference was not statistically significant, however, and the unadjusted and adjusted log odds ratios for the incidence of adverse events were similar to those for placebo.
Gill et al conclude in the journal Circulation: “Using rFVIIa in patients bleeding after cardiac surgery may be beneficial, but caution should be applied and further clinical trials are required.”
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