Fibrinogen in Haemorrhage of Delivery (FIDEL)

September 3, 2020 updated by: Laboratoire français de Fractionnement et de Biotechnologies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Antony, France, 92160
        • Hopital Prive d'Antony
      • Bourg en Bresse, France, 01012
        • Centre Hospitalier Fleyriat
      • Bron, France, 69500
        • Hôpital Femme Mère Enfant
      • Clamart, France, 92141
        • Hôpital Antoine Béclère
      • Clermont-Ferrand, France, 63000
        • CHU Estaing
      • Colombes, France, 92701
        • Hôpital Louis Mourier
      • Le Coudray, France, 28630
        • Les Hôpitaux de Chartres (Hôpital Pasteur)
      • Le Kremlin-bicetre, France, 94275
        • Hôpital Bicêtre
      • Lens, France, 62307
        • Centre Hospitalier de LENS
      • Lille, France, 59037
        • CHU de Lille, Maternité Jeanne de Flandre
      • Limoges, France, 87042
        • CHU de Limoges
      • Lyon, France, 69004
        • Hôpital de la Croix Rousse
      • Marseille, France, 13008
        • Hôpital Saint-Joseph / Pôle Parents - Enfants
      • Montpellier, France, 34295
        • CHRU de Montpellier
      • Nancy, France, 54042
        • Maternité Régionale Universitaire de Nancy
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75679
        • Hopital Cochin
      • Paris, France, 75015
        • Hôpital Necker - Enfants Malades
      • Paris, France, 75571
        • Hôpital Armand Trousseau
      • Reims, France, 51092
        • CHU de Reims, Hôpital Maison Blanche
      • Rennes, France, 35203
        • CHU de Rennes - Hôpital Sud
      • Saint-Herblain, France, 44819
        • Polyclinique de l'Atlantique
      • Strasbourg, France, 67200
        • Hopital de Hautepierre
      • Suresnes, France, 92151
        • Hopital Foch
      • Toulouse, France, 31059
        • Hôpital Paul de Viguier - Site Purpan
      • Tours, France, 37044
        • CHU de Tours
      • Valenciennes, France, 59300
        • Ch de Valenciennes
    • Réunion
      • Saint Denis, Réunion, France, 97405
        • CH Felix Guyon
      • Saint Pierre, Réunion, France, 97448
        • Groupe Hospitalier Sud Réunion
  • Martinique
      • Fort de France, Martinique, 97261
        • CHR de Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure Rate of PPH Management
Time Frame: 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.
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
Time Frame: from H0 to Day 2
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
Time Frame: From reference value to Day 2
Considering failure as the fact of having lost at least 4 g/dL of Hb.
From reference value to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

  • Principal Investigator: Anne-Sophie DUCLOY-BOUTHORS, Dr, Maternité Jeanne de Flandre - 59037 LILLE
  • Study Chair: Frédéric MERCIER, Pr, Hôpital Antoine Béclère - 92140 CLAMART
  • Study Chair: Alexandre MIGNON, Pr, Hôpital Cochin - 75014 PARIS
  • Study Chair: Cyril HUISSOUD, Pr, Hôpital Croix Rousse - 69004 LYON
  • Study Chair: Jean-Marie GROUIN, Université de Rouen - 76100 ROUEN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 10, 2014

Primary Completion (Actual)

August 6, 2018

Study Completion (Actual)

August 6, 2018

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIDEL
  • 2013-002484-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-Partum Hemorrhage

Clinical Trials on Human Fibrinogen concentrate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe