Fibrinogen in Haemorrhage of Delivery

Study Overview
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Brief Summary
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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
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Randomised, double-blind,multicenter, placebo-controlled study

Official Title
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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

Conditions
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Post-Partum Hemorrhage

Intervention / Treatment
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* Drug: Human Fibrinogen concentrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Administration of FFP, platelets units or prohaemostatic drugs, tranexamic acid and rFVIIa or prothrombin complex concentrates (PCC) within 48 hours prior to the inclusion Administration of RBCs within 3 months prior to the inclusion Participation in another interventional clinical study within 30 days prior to the inclusion Previous inclusion/enrolment in the present clinical study Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom Known drug or alcohol abuse Patients whose use of concomitant medication may interfere with the interpretation of data Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement Patients who are unlikely to survive through the treatment period and evaluation Patients transferred from another service

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Fibrinogen concentrate<br>2 vials (200ml) / 3g intravenous | Drug: Human Fibrinogen concentrate<br>* Injection as soon as possible and within 30 min following the start of prostaglandin infusion<br>* Other names: Clottafact, LFB;|
| Placebo Comparator: Placebo<br>2 vials (200ml) | Drug: Placebo<br>* As soon as possible and within 30 min following the start of prostaglandin infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure Rate of PPH Management | 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. | Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With at Least Administration of 2 Units of RBCs | Considering failure as the fact of requiring at least 2 units of RBCs. | from H0 to Day 2 | 
| Patients With Loss of at Least 4 g/dL of Hb | Considering failure as the fact of having lost at least 4 g/dL of Hb. | From reference value to Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPH, fibrinogen, vaginal delivery