Fibrinogen in Haemorrhage of Delivery

Phase 4

Completed

Conditions: Post-Partum Hemorrhage

Interventions: Drug: Human Fibrinogen concentrate
Drug: Placebo

Registration Number: NCT02155725

Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 448

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Fibrinogen concentrate	Human Fibrinogen concentrate	2 vials (200ml) / 3g intravenous
Placebo	Placebo	2 vials (200ml)

Primary Outcome Measures

Name	Time	Method
Failure Rate of PPH Management	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 Outcome Measures

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

Trial Locations

Locations (31): CH Félix Guyon
🇫🇷
Saint Denis, Réunion, France
Groupe Hospitalier Sud Réunion
🇫🇷
Saint Pierre, Réunion, France
Hôpital Privé d'Antony
🇫🇷
Antony, France
CHU d'Angers
🇫🇷
Angers, France
Centre Hospitalier Fleyriat
🇫🇷
Bourg en Bresse, France
Hôpital Femme Mère Enfant
🇫🇷
Bron, France
Hôpital Antoine Béclère
🇫🇷
Clamart, France
CHU Estaing
🇫🇷
Clermont-Ferrand, France
Hôpital Louis Mourier
🇫🇷
Colombes, France
Hôpital Bicêtre
🇫🇷
Le Kremlin-bicetre, France
Centre Hospitalier de Lens
🇫🇷
Lens, France
Les Hôpitaux de Chartres (Hôpital Pasteur)
🇫🇷
Le Coudray, France
CHU de Limoges
🇫🇷
Limoges, France
CHU de Lille, Maternité Jeanne de Flandre
🇫🇷
Lille, France
Hôpital de la Croix Rousse
🇫🇷
Lyon, France
Maternité Régionale Universitaire de Nancy
🇫🇷
Nancy, France
Hôpital Saint-Joseph / Pôle Parents - Enfants
🇫🇷
Marseille, France
CHRU de Montpellier
🇫🇷
Montpellier, France
Hôpital Armand Trousseau
🇫🇷
Paris, France
Hôpital Necker - Enfants malades
🇫🇷
Paris, France
Hôpital Cochin
🇫🇷
Paris, France
Hôpital Tenon
🇫🇷
Paris, France
CHU de Reims, Hôpital Maison Blanche
🇫🇷
Reims, France
Hôpital de Hautepierre
🇫🇷
Strasbourg, France
Hôpital Foch
🇫🇷
Suresnes, France
CHU de Rennes - Hôpital Sud
🇫🇷
Rennes, France
Polyclinique de l'Atlantique
🇫🇷
Saint-Herblain, France
Hôpital Paul de Viguier - Site Purpan
🇫🇷
Toulouse, France
CHU de Tours
🇫🇷
Tours, France
CH de Valenciennes
🇫🇷
Valenciennes, France
CHR de Martinique
🇲🇶
Fort de France, Martinique