Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery
Overview
- Phase
- Phase 4
- Intervention
- Human Fibrinogen concentrate
- Conditions
- Post-Partum Hemorrhage
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Enrollment
- 448
- Locations
- 31
- Primary Endpoint
- Failure Rate of PPH Management
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.
Detailed Description
Randomised, double-blind,multicenter, placebo-controlled study
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed and dated informed consent form
- •Vaginal delivery
- •PPH requiring IV administration of prostaglandins
- •At least one available result of Hb level during the third trimester of pregnancy
- •18-year-old female patients and older
- •Covered by healthcare insurance in accordance with local requirements
Exclusion Criteria
- •Caesarean section
- •Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
- •Known placenta praevia or accreta
- •Hb level \< 10g/dl during the third trimester of pregnancy
- •History of venous or arterial thromboembolic event
- •Known inherited bleeding or thrombotic disorders
- •Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
- •Treatment with acetylsalicylic acid within 5 days prior to the inclusion
- •Treatment with vitamin K antagonists within 7 days prior to the inclusion
- •Administration of fibrinogen concentrate within 48 hours prior to the inclusion
Arms & Interventions
Human Fibrinogen concentrate
2 vials (200ml) / 3g intravenous
Intervention: Human Fibrinogen concentrate
Placebo
2 vials (200ml)
Intervention: Placebo
Outcomes
Primary Outcomes
Failure Rate of PPH Management
Time Frame: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
The primary efficacy variable is a binary (Failure versus Success) composite endpoint. Failure is defined when a patient: * loses at least 4 g/dL of Hb compared to the reference Hb level , AND/OR * requires the transfusion of at least 2 units of packed RBCs.
Secondary Outcomes
- Patients With at Least Administration of 2 Units of RBCs(from H0 to Day 2)
- Patients With Loss of at Least 4 g/dL of Hb(From reference value to Day 2)