Overview

rhuFVIIa in Post-partum Hemorrhage

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborators:
Assistance Publique - Hôpitaux de Paris
Centre Hospitalier Universitaire de Nice
University Hospital, Geneva
University Hospital, Lille
University Hospital, Montpellier
Criteria
Inclusion Criteria:

- Severe postpartum hemorrhage, i.e non responsive to sulprostone infusion

Exclusion Criteria:

- < 18 years

- personal antecedent of arterial or venous thrombosis

- written informed consent not approved/signed by the patient or her husband