Study on the efficacy and safety of a therapeutic strategy of post partum haemorrhage comparing early administration of human fibrinogen versus placebo in patients treated with intravenous prostaglandins following vaginal delivery.

Phase 1

• Conditions: post partum haemorrhage following vaginal delivery; MedDRA version: 18.0Level: LLTClassification code 10036294Term: Postpartum haemorrhage (primary)System Organ Class: 100000004868; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-002484-26-FR
• Lead Sponsor: FB Biomédicaments

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-24
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 434

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 434
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectve 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.;Secondary Objective: The secondary objectives are: <br>•To assess the evolution of haemorrhage<br>•To assess the need for haemostatic intervention<br>•To assess the maternal morbi-mortality<br>•To assess the biological effects of fibrinogen concentrate administration<br>•To assess the tolerance of fibrinogen concentrate administration<br>;Primary end point(s): Percentage of patients losing at least 4 g/dl of Hb, and/or requiring the transfusion of at least 2 units of packed RBCs within the 48 hours following the administration of IMP.<br>The reference for Hb level is the most recent value recorded during the third trimester of pregnancy.<br>;Timepoint(s) of evaluation of this end point: 48h following the IMP administration.