NCT00370877

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_4

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

3.6 years

First QC Date

August 30, 2006

Last Update Submit

March 26, 2015

Conditions

Postpartum Hemorrhage

Keywords

Post-partum hemorrhageArterial embolizationSurgeryHysterectomyActivated recombinant human factor VII

Outcome Measures

Primary Outcomes (4)

  • Clinical parameters: intensity of the hemorrhage, before and one hour after the end of the rhuFVIIa infusion (use of a graduated blood collector bag device).

    1 hour

  • Any transfusion (number of units and volume) of red blood cells, platelet or fresh frozen plasma. Haemodynamics-related parameters (non-invasive arterial pressure,heart rate, diuresis,..).

    7 Hours

  • Biological parameters:packed red cell volume, hemoglobin, etc.

    12 hours

  • Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy.

    Day 1

Study Arms (2)

Standard care for post-partum hemorrhage

ACTIVE COMPARATOR

The patients included in this arm of the study will recieve standard care for post-partum hemorrhage.

Procedure: Standard Care

rFVIIa

EXPERIMENTAL

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)

Drug: rFVIIa

Interventions

rFVIIaDRUG

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)

Also known as: Experimental, Novo 7, eptacog alpha (activated)
rFVIIa
Standard CarePROCEDURE

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

Also known as: Standard
Standard care for post-partum hemorrhage

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \< 18 years
  • personal antecedent of arterial or venous thrombosis
  • written informed consent not approved/signed by the patient or her husband

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital, Lille

Lille, Lille, France

Location

University Hospital of Montpellier

Montpellier, Montpellier, France

Location

University Hospital, Nice

Nice, Nice, France

Location

Hôpital Antoine Béclère -APHP

Clamart, France

Location

Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau

Nîmes, F-30029, France

Location

Centre Hospital University of Nimes

Nîmes, France

Location

Maternite CHU de Cochin - APHP

Paris, France

Location

University Hospital, Geneva

Geneva, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25594352DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

recombinant FVIIaStandard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jean-Christophe Gris, MD, PhD

    University Hospital, Nimes, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

April 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

CH(1)FR(7)