search
Back to results

rhuFVIIa in Post-partum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
rFVIIa
Standard Care
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Post-partum hemorrhage, Arterial embolization, Surgery, Hysterectomy, Activated recombinant human factor VII

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Antoine Béclère -APHP
  • University Hospital, Lille
  • University Hospital of Montpellier
  • University Hospital, Nice
  • Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau
  • Centre Hospital University of Nimes
  • Maternite CHU de Cochin - APHP
  • University Hospital, Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care for post-partum hemorrhage

rFVIIa

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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).
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,..).
Biological parameters:packed red cell volume, hemoglobin, etc.
Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2006
Last Updated
March 26, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
University Hospital, Lille, Assistance Publique - Hôpitaux de Paris, University Hospital, Montpellier, University Hospital, Geneva, Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT00370877
Brief Title
rhuFVIIa in Post-partum Hemorrhage
Official Title
Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
University Hospital, Lille, Assistance Publique - Hôpitaux de Paris, University Hospital, Montpellier, University Hospital, Geneva, Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Depending on the country and the publications, postpartum hemorrhage is either the first or the second cause of maternal death in the world, including developed countries. According to the WHO, it is responsible for twenty two percent of maternal deaths. In France, postpartum hemorrhage accounts for five percent of delivery complications. Three percent of them are severe, leading to uncontrolled bleeding which intensity is higher than 1000 ml of blood during the 24 hours following delivery. In France, they are involved in 20 new deaths per year; it is the first cause of maternal mortality. Indeed, it remains a significant source of morbidity: severe anaemia, blood transfusion, transfusion complications, acquired coagulation disorders and hemostatic hysterectomy. There are two different types of postpartum hemorrhage: early and late hemorrhages. Early hemorrhages are more common and occur in the first 24H after delivery. Uterine atony is the main cause of early hemorrhage. However, visual assessment underestimates the amount of blood loss in around forty five percent of cases. Emergency treatment is therefore sometimes undertaken with some delay, giving time for disseminated intravascular coagulation (DIC) to occur, which worsens the prognosis. They are usually treated by medical resuscitation, blood transfusion, selective arterial embolisation and finally hysterectomy in case of ongoing uncontrolled bleeding. Medical treatment and obstetric manoeuvres are usually effective. Artificial delivery of the placenta should be performed immediately if the placenta is incomplete. Afterwards, oxytocin and prostaglandin derivatives are given. At the same time, anemia and hemostatic abnormalities are treated by transfusion of fresh frozen plasma and packed cells. When the measures are insufficient, surgery is necessary. Bilateral ligation of hypogastric arteries or controlled embolisation is recommended. In the case of uncontrolled bleeding, hemostatic hysterectomy is performed as a salvage therapy. Also, the efficacy of ligation of the hypogastric arteries remains controversial. Therefore, the success rate of ligation of the hypogastric arteries is only forty two percent, so that in many cases hysterectomy is required, which induces a definitive sterility. The development of interventional radiology has offered a new approach for the management of postpartum hemorrhage. Many publications have showed the usefulness of the procedure, whose success rate is around ninety percent. However, a specific technical plateau is needed, which is far to be available at any place and at any moment. For patients delivering far away from these technical sites, limiting blood loss is crucial. Among the methods aiming at limiting obstetrical hemorrhage, special concern was given to recombinant activated factor VII, a drug used with good therapeutic results in symptomatic patients with hemophilia and inhibitors. It has already been applied in interventions situations. Taking into consideration the above described aspects, our goal is thus to evaluate the potential medical interest of giving rhFVIIa early in the course of hemorrhage, compared to giving it as a salvage therapy after arterial selective embolization or hysterectomy in patients still bleeding, in order to avoid hemostatic hysterectomy. In the literature, IV infusion of rFVIIa stopped ongoing diffuse hemorrhage, rapidly, and no further transfusion was required after rFVIIa injection. Then rFVIIa, might be a strong complementary agent in the management of major postpartum hemorrhage. Optimal dose, timing and safety characteristics of rFVIIa administration remain to be determined. Therefore, the main objectives of the study are: to evaluate the reduction of the absolute risk of arterial embolization/surgery/hysterectomy in patients receiving a unique early infusion of rhuFVIIa (60 µg/kg body weight); to evaluate the number of women necessary to treat to avoid one arterial embolization/surgery/hysterectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Post-partum hemorrhage, Arterial embolization, Surgery, Hysterectomy, Activated recombinant human factor VII

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care for post-partum hemorrhage
Arm Type
Active Comparator
Arm Description
The patients included in this arm of the study will recieve standard care for post-partum hemorrhage.
Arm Title
rFVIIa
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
rFVIIa
Other Intervention Name(s)
Experimental, Novo 7, eptacog alpha (activated)
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Standard
Intervention Description
Patients will recieve standard care for post partum hemorrhage according to current recommendations.
Primary Outcome Measure Information:
Title
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).
Time Frame
1 hour
Title
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,..).
Time Frame
7 Hours
Title
Biological parameters:packed red cell volume, hemoglobin, etc.
Time Frame
12 hours
Title
Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy.
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Gris, MD, PhD
Organizational Affiliation
University Hospital, Nimes, France
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Antoine Béclère -APHP
City
Clamart
Country
France
Facility Name
University Hospital, Lille
City
Lille
Country
France
Facility Name
University Hospital of Montpellier
City
Montpellier
Country
France
Facility Name
University Hospital, Nice
City
Nice
Country
France
Facility Name
Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau
City
Nimes cedex 9
ZIP/Postal Code
F-30029
Country
France
Facility Name
Centre Hospital University of Nimes
City
Nimes
Country
France
Facility Name
Maternite CHU de Cochin - APHP
City
Paris
Country
France
Facility Name
University Hospital, Geneva
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25594352
Citation
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.
Results Reference
derived

Learn more about this trial

rhuFVIIa in Post-partum Hemorrhage

We'll reach out to this number within 24 hrs