Activated Recombinant Human Coagulation Factor VII Therapy for Intracranial Hemorrhage in Patients with Hemophilia A or B with Inhibitors

Autor: S. Miller, J.J. Hutter, H.A. Cooper, I. Warrier, M.L. Schmidt, N.L. Seibel, Steven Arkin, A. Shapiro
Rok vydání: 1998
Předmět:
Zdroj: Pathophysiology of Haemostasis and Thrombosis. 28:93-98
ISSN: 1424-8840
1424-8832
DOI: 10.1159/000022418
Popis: Activated recombinant human coagulation factor VII (rFVIIa) is a promising new therapeutic agent for patients with hemophilia A or B with inhibitors who experience serious bleeding episodes or who need coverage during surgical procedures. This open-label, uncontrolled, emergency-use study evaluated the efficacy and safety of rFVIIa in 11 hemophiliac patients and 1 FVII-deficient patient with life-threatening intracranial hemorrhage previously unresponsive to one or more alternative therapies. rFVIIa effectively controlled intracranial hemorrhage in 10 of the 12 patients. Patients with hemophilia A or B received an average of 96.9 rFVIIa injections over 14.7 days with a mean total administration of 153.3 mg, corresponding to 8.1 mg/kg. Most reported adverse events were considered to be unrelated to rFVIIa therapy. These findings suggest that rFVIIa is an effective and well-tolerated therapeutic option in the management of central nervous system bleeding in patients with hemophilia A or B with inhibitors.
Databáze: OpenAIRE