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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
448

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital Privé d'Antony
      • Bourg en Bresse, France, 01012
        • Centre hospitalier Fleyriat
      • Bron, France, 69500
        • Hôpital Femme Mère Enfant
      • Clamart, France, 92141
        • Hopital Antoine Beclere
      • 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
        • Hopital 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
        • Hôpital Tenon
      • Paris, France, 75679
        • Hopital Cochin
      • Paris, France, 75015
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratoire français de Fractionnement et de Biotechnologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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