- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370877
rhuFVIIa in Post-partum Hemorrhage
Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Clamart, France
- Hôpital Antoine Béclère -APHP
-
Lille, France
- University Hospital, Lille
-
Montpellier, France
- University Hospital of Montpellier
-
Nice, France
- University Hospital, Nice
-
Nimes, France
- Centre Hospital University of Nimes
-
Nimes cedex 9, France, F-30029
- Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau
-
Paris, France
- Maternite CHU de Cochin - APHP
-
-
-
-
-
Geneva, Switzerland
- University Hospital, Geneva
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard care for post-partum hemorrhage
The patients included in this arm of the study will recieve standard care for post-partum hemorrhage.
|
Patients will recieve standard care for post partum hemorrhage according to current recommendations.
Other Names:
|
EXPERIMENTAL: 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)
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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,..).
Time Frame: 7 Hours
|
7 Hours
|
Biological parameters:packed red cell volume, hemoglobin, etc.
Time Frame: 12 hours
|
12 hours
|
Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy.
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jean-Christophe Gris, MD, PhD, University Hospital, Nimes, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-I/2005/GL-01
- 2005-005801-40 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Hemorrhage
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedPostpartum Haemorrhage | Immediate Postpartum HemorrhageFrance
-
University Hospital, Clermont-FerrandUnknownPostpartum Depression | Postpartum Hemorrhage | Postpartum Women | Postpartum Stress | Postpartum AnxietyFrance
-
ResQ Medical LtdNot yet recruitingPPH | Postpartum Hemorrhage \(PPH\) | Postpartum Hemorrhage \(Primary\)Kenya
-
Cairo UniversityUnknownHemorrhage, PostpartumEgypt
-
Columbia UniversityCompletedHemorrhage, PostpartumUnited States
-
Ain Shams Maternity HospitalUnknownHemorrhage PostpartumEgypt
-
Chelsea and Westminster NHS Foundation TrustCompleted
-
Megan LordThermaSENSE CorpCompletedHemorrhage | Vasoconstriction | Hemorrhage, PostpartumUnited States
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedImmediate Postpartum HemorrhageFrance
-
Gynuity Health ProjectsAga Khan Health ServicesCompletedPostpartum Hemorrhage (PPH)Afghanistan
Clinical Trials on Standard Care
-
Evandro Chagas Institute of Clinical ResearchAlejandro Marcel Hasslocher Moreno, MD MSc PhD student; Andrea Costa, MD PhD; Andrea Silvestre de Sousa, MD PhD and other collaboratorsUnknownChagas Heart DiseaseBrazil
-
Neuroscience Trials AustraliaNational Institute for Health Research, United Kingdom; Northern Ireland Chest... and other collaboratorsCompleted
-
University of OklahomaNational Cancer Institute (NCI)CompletedSmoking CessationUnited States
-
Avita MedicalNAMSACompletedVenous Leg UlcersUnited Kingdom, France
-
University of MichiganCompleted
-
University of OklahomaCompletedTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency ManagementUnited States
-
University of OklahomaEnrolling by invitationTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency Management | PregnancyUnited States
-
Institut de Cancérologie de LorraineTerminatedBreast CancerFrance
-
Indonesia UniversityCompletedCovid19 | AcupunctureIndonesia
-
Johns Hopkins UniversityRecruitingCompartment Syndrome of Leg | Extracorporeal Membrane Oxygenation Complication | Limb Ischemia, Critical | Limb IschemiaUnited States