Clinical trial NCT02155725: Fibrinogen in Haemorrhage of Delivery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Partum Hemorrhage
Keywords: PPH
fibrinogen
vaginal delivery
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 448
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* 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

Primary outcomes:
measure: Failure Rate of PPH Management
timeFrame: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
Secondary outcomes:
measure: Patients With at Least Administration of 2 Units of RBCs
timeFrame: from H0 to Day 2
measure: Patients With Loss of at Least 4 g/dL of Hb
timeFrame: From reference value to Day 2
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: CH Félix Guyon
state: Réunion
city: Saint Pierre
country: France
facility: Groupe Hospitalier Sud Réunion
state: Réunion
city: Angers
country: France
facility: CHU d'Angers
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Bourg en Bresse
country: France
facility: Centre Hospitalier Fleyriat
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Le Coudray
country: France
facility: Les Hôpitaux de Chartres (Hôpital Pasteur)
city: Le Kremlin-bicetre
country: France
facility: Hôpital Bicêtre
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille
country: France
facility: CHU de Lille, Maternité Jeanne de Flandre
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Hôpital Saint-Joseph / Pôle Parents - Enfants
city: Montpellier
country: France
facility: CHRU de Montpellier
city: Nancy
country: France
facility: Maternité Régionale Universitaire de Nancy
city: Paris
country: France
facility: Hôpital Necker - Enfants malades
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Tenon
city: Reims
country: France
facility: CHU de Reims, Hôpital Maison Blanche
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Sud
city: Saint-Herblain
country: France
facility: Polyclinique de l'Atlantique
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Hôpital Paul de Viguier - Site Purpan
city: Tours
country: France
facility: CHU de Tours
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Fort de France
country: Martinique
facility: CHR de Martinique
Study officials:
affiliation: Maternité Jeanne de Flandre - 59037 LILLE
name: Anne-Sophie DUCLOY-BOUTHORS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Antoine Béclère - 92140 CLAMART
name: Frédéric MERCIER, Pr
role: STUDY_CHAIR
affiliation: Hôpital Cochin - 75014 PARIS
name: Alexandre MIGNON, Pr
role: STUDY_CHAIR
affiliation: Hôpital Croix Rousse - 69004 LYON
name: Cyril HUISSOUD, Pr
role: STUDY_CHAIR
affiliation: Université de Rouen - 76100 ROUEN
name: Jean-Marie GROUIN
role: STUDY_CHAIR
References:
citation: Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.