rhuFVIIa in Post-partum Hemorrhage

Phase 4 Completed 84 enrolled Nîmes University Hospital Assistance Publique - Hôpitaux de Paris · collab Centre Hospitalier Universitaire de Nice · collab University Hospital, Geneva · collab University Hospital, Lille · collab University Hospital, Montpellier · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.

Timeline

Start: 2007-04
Primary completion: 2010-11
Completion: 2010-11

Publications

Lavigne-Lissalde G, Aya AG, Mercier FJ, Roger-Christoph S, Chauleur C, Morau E, Ducloy-Bouthors AS, Mignon A, Raucoules M, Bongain A, Boehlen F, de Moerloose P, Bouvet S, Fabbro-Peray P, Gris JC. Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial. J Thromb Haemost. 2015 Apr;13(4):520-9. doi: 10.1111/jth.12844. Epub 2015 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	eptacog alfa (activated)	Protein / enzyme biologic	60 ug/kg	Intravenous

Indications

No indication recorded.