J Ingerslev1, T Vanek, S Culic. 1. Centre for Hemophilia and Thrombosis, University Hospital Skejby, Denmark. ingerslev@ki.au.dk
Abstract
CONTEXT: There is limited data regarding the use of activated recombinant factor VII (rFVIIa) in anticoagulated patients requiring reversal. AIMS: To identify and describe characteristics of subjects who received rFVIIa as part of emergency treatment aimed at improving hemostasis. SETTINGS AND DESIGN: Data was obtained from an international peer-reviewed registry haemostasis.com. This registry contains data reported by physicians, who had elected to use rFVIIa to control bleeding in an emergency clinical situation. The contributors' approval for inclusion in the study was obtained and they were requested to validate and update information. MATERIALS AND METHODS: Database review of cases receiving rFVIIa to manage bleeding coherent with the use of anticoagulant therapy. STATISTICAL ANALYSIS: The Wilcoxon signed rank test was used to compare requirements for blood products and crystalloids/colloids during the 24h preceding and following rFVIIa administration, as well as changes in the levels of clotting factors during that period. RESULTS: Eighteen patients were treated with rFVIIa (median dose: 87.35 microg/kg; range: 20.0-106.0 microg/kg) for bleeding. Anticoagulants requiring reversal included low-molecular-weight heparin (n = 6), unfractionated heparin (n =8), coumarin (n =3) and warfarin (n=1). All patients had failed to respond to traditional antidotes and blood products. Following administration, bleeding stopped in 10, markedly decreased in five and slowed in the remaining three. Amongst 12/16 patients, a response was observed within 2.0 h of first administration. The requirement for blood products and crystalloids/colloids decreased ( P < 0.05) after rFVIIa administration. rFVIIa was well tolerated. CONCLUSIONS: rFVIIa may play a role in control of untoward bleeding in subjects receiving anticoagulation therapy.
CONTEXT: There is limited data regarding the use of activated recombinant factor VII (rFVIIa) in anticoagulated patients requiring reversal. AIMS: To identify and describe characteristics of subjects who received rFVIIa as part of emergency treatment aimed at improving hemostasis. SETTINGS AND DESIGN: Data was obtained from an international peer-reviewed registry haemostasis.com. This registry contains data reported by physicians, who had elected to use rFVIIa to control bleeding in an emergency clinical situation. The contributors' approval for inclusion in the study was obtained and they were requested to validate and update information. MATERIALS AND METHODS: Database review of cases receiving rFVIIa to manage bleeding coherent with the use of anticoagulant therapy. STATISTICAL ANALYSIS: The Wilcoxon signed rank test was used to compare requirements for blood products and crystalloids/colloids during the 24h preceding and following rFVIIa administration, as well as changes in the levels of clotting factors during that period. RESULTS: Eighteen patients were treated with rFVIIa (median dose: 87.35 microg/kg; range: 20.0-106.0 microg/kg) for bleeding. Anticoagulants requiring reversal included low-molecular-weight heparin (n = 6), unfractionated heparin (n =8), coumarin (n =3) and warfarin (n=1). All patients had failed to respond to traditional antidotes and blood products. Following administration, bleeding stopped in 10, markedly decreased in five and slowed in the remaining three. Amongst 12/16 patients, a response was observed within 2.0 h of first administration. The requirement for blood products and crystalloids/colloids decreased ( P < 0.05) after rFVIIa administration. rFVIIa was well tolerated. CONCLUSIONS: rFVIIa may play a role in control of untoward bleeding in subjects receiving anticoagulation therapy.