Use of recombinant factor VIIa in uncontrolled gastrointestinal bleeding after hematopoietic stem cell transplantation among patients with thrombocytopenia

Background and Objective: Recombinant-activated factor VII (rVIIa) is a vitamin K-dependent glycoprotein that is an analog of the naturally occurring protease. It has an off-label use to control life-threatening bleeding that is refractory to other measures and was shown to decrease transfusion requirements. Gastrointestinal (GI) bleeding is a severe complication following hematopoietic stem cell transplantation (HSCT) in patients with thrombocytopenia, while hemostatic measures based on antifibrinolytic or transfusion therapy may not always be successful. The present study investigated the treatment with rFVIIa in severe GI bleeding among thrombocytopenia patients undergoing HSCT.

Methods: rFVIIa was given as a single dose of 60μg/kg in patients with GI bleeding following hematopoietic stem cell transplantation (HSCT).

Results: Among all patients enrolled, 12 (75%) of 16 patients obtained a response, of which 5 achieved a complete response and 7 achieved a partial response. The 4 remiaing patients (25%) had no response. Nine patients (56.3%) died in a follow-up of 90 days. No thromboembolic events wereassociated with the drug administration occurred.

Conclusions: Our study showed that rFVIIa may represent an additional therapeutic option in such cases.