title: Control of bleeding caused by thrombocytopenia associated with hematologic malignancy: an audit of the clinical use of recombinant activated factor VII.
abstract: This paper presents an analysis of 24 cases in which recombinant factor VIIa (rFVIIa) was used in the management of hemorrhage in patients with thrombocytopenia associated with hematologic malignancies. This is the largest case aggregation to date and focuses on preliminary experience in the off-label use of this hemostatic agent. Data were extracted from the international, Internet-based registry, www.haemostasis.com, accessed in September 2003. The search results were manually cross-checked against monthly summary reports. The physicians providing the cases were contacted individually to approve the use of their cases, supply any information missing from the database, and validate the data already held. Patients with acute myeloid leukemia, acute lymphoblastic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, Burkitt's lymphoma, B-cell or T-cell lymphoma, or aplastic anemia received rFVIIa at total doses of between 18 and 1040 mug/kg body weight. Bleeding stopped in 11 of 24 (46%) patients, markedly decreased in 8 of 24 (33%) patients, and decreased in 4 of 24 (17%) patients. In most patients, the response was achieved within 2.5 hours of administration of rFVIIa. The use of rFVIIa was generally well tolerated -- 1 case of ischemic stroke was considered to be possibly related to rFVIIa administration, but this has yet to be confirmed. A review of these 24 cases submitted to the www.haemostasis.com database suggests that rFVIIa is beneficial in the management of hemorrhage in patients with thrombocytopenia and hematologic malignancies. This warrants further investigation in rigorously controlled clinical trials.
authors.affiliation: Thrombosis and Hemostasis Unit, Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, Haifa, Israel. b_brenner@rambam.health.gov.il
authors.forename: Benjamin
authors.initials: B
authors.lastname: Brenner
authors.forename: Ron
authors.initials: R
authors.lastname: Hoffman
authors.forename: Dmitriy
authors.initials: D
authors.lastname: Balashov
authors.forename: Elena
authors.initials: E
authors.lastname: Shutluko
authors.forename: Sr Dana
authors.initials: SD
authors.lastname: Culić
authors.forename: Elena
authors.initials: E
authors.lastname: Nizamoutdinova
mesh_terms: D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D020407:Internet; D007938:Leukemia / Q000097:blood / Q000150:complications*; D008223:Lymphoma / Q000097:blood / Q000150:complications*; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D011516:Prothrombin / Q000378:metabolism; D013921:Thrombocytopenia / Q000097:blood / Q000150:complications*; D013925:Thromboplastin / Q000378:metabolism
chemical_list: D000925:Anticoagulants; D011516:Prothrombin; D013925:Thromboplastin; D015942:Factor VIIa