Journal of thrombosis and haemostasis : JTH
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J. Thromb. Haemost. · Sep 2005
Randomized Controlled Trial Multicenter Study Clinical TrialRecombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation.
Bleeding is a common complication following hematopoietic stem cell transplantation (HSCT) and standard hemostatic treatment is often ineffective. We conducted a multicentre, randomized trial of the efficacy and safety of activated recombinant factor VII (rFVIIa, NovoSeven) in the treatment of bleeding following HSCT. ⋯ Despite no overall effect of rFVIIa treatment on primary endpoint, post hoc analysis showed an improvement in the control of bleeding for 80 microg kg(-1) rFVIIa vs. standard hemostatic treatment. The heterogeneity of the population may have contributed to the lack of an increasing effect with increased dose. Further trials should focus upon identifying the patient populations that may benefit from treatment with rFVIIa.