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rhuFVIIa in Post-partum Hemorrhage

NCT00370877 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-03-27

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

rFVIIa

The patients included in this arm of the study will recieve standard care for post-partum hemorrhage plus a slow intravenous injection (2ml/min) of rFVIIa (60µg/kg)

PROCEDURE

Standard Care

Patients will recieve standard care for post partum hemorrhage according to current recommendations.

Sponsors & Collaborators

  • University Hospital, Lille

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • University Hospital, Montpellier

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nice

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Jean-Christophe Gris, MD, PhD · University Hospital, Nimes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370877 on ClinicalTrials.gov