Fibrinogen in Haemorrhage of Delivery

Post-Partum Hemorrhage Clinical Trial

— FIDEL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155725
• Other study ID #: FIDEL
• Secondary ID: 2013-002484-26
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2014
• Est. completion date: August 6, 2018

Study information

• Verified date: July 2020
• Source: Laboratoire français de Fractionnement et de Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomised, double-blind,multicenter, placebo-controlled study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Post-Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Human Fibrinogen concentrate
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
• Placebo
As soon as possible and within 30 min following the start of prostaglandin infusion

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	Hôpital Privé d'Antony	Antony
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	Les Hôpitaux de Chartres (Hôpital Pasteur)	Le Coudray
France	Hôpital Bicêtre	Le Kremlin-bicetre
France	Centre Hospitalier de Lens	Lens
France	CHU de Lille, Maternité Jeanne de Flandre	Lille
France	CHU de Limoges	Limoges
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Saint-Joseph / Pôle Parents - Enfants	Marseille
France	CHRU de Montpellier	Montpellier
France	Maternité Régionale Universitaire de Nancy	Nancy
France	Hôpital Armand Trousseau	Paris
France	Hôpital Cochin	Paris
France	Hôpital Necker - Enfants malades	Paris
France	Hôpital Tenon	Paris
France	CHU de Reims, Hôpital Maison Blanche	Reims
France	CHU de Rennes - Hôpital Sud	Rennes
France	CH Félix Guyon	Saint Denis	Réunion
France	Groupe Hospitalier Sud Réunion	Saint Pierre	Réunion
France	Polyclinique de l'Atlantique	Saint-Herblain
France	Hôpital de Hautepierre	Strasbourg
France	Hôpital Foch	Suresnes
France	Hôpital Paul de Viguier - Site Purpan	Toulouse
France	CHU de Tours	Tours
France	CH de Valenciennes	Valenciennes
Martinique	CHR de Martinique	Fort de France

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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