Recombinant Factor VIIA in the Treatment of Bleeding

Madhu V. Midathada, MD; Paulette Mehta, MD; Milton Waner, MD; Louis M. Fink, MD


Am J Clin Pathol. 2004;121(1) 

In This Article


rFVIIa has been used to control traumatic bleeding.[111,112] Life-threatening bleeding associated with trauma that was not corrected by other means was reported to have been controlled effectively with rFVIIa.[26,27,61,111] Rebleeding following subarachnoid hemorrhage is a major concern, and antifibrinolytic agents have been used to prevent it, but they increase the risk of cerebral ischemia and infarction. An open-label, dose-escalation study was conducted with rFVIIa in 10 patients with subarachnoid hemorrhage.[113] There was no evidence of cerebral ischemia in 9 of the treated patients; middle cerebral artery branch thrombosis contralateral to the aneurysm developed in the last patient. Data from 2 compassionate use clinical trials using rFVIIa to treat central nervous system bleeding in 18 patients with hemophilia A with high-titer inhibitors and 3 patients with factor VII deficiency showed an overall efficacy of 84% with only 1 death.[114] No major adverse effects were reported.

Massive pulmonary hemorrhage secondary to trauma in a 44-year-old man, which was uncontrolled with standard treatment, was controlled successfully with rFVIIa.[115] In another case, rFVIIa was used successfully to control massive hemoptysis in acute leukemia.[116]


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