Post-Partum HemorrhagePhase 4FIDELNCT02155725
Fibrinogen in Haemorrhage of Delivery
A Phase 4 study testing Human Fibrinogen concentrate in people with Post-Partum Hemorrhage, run by Laboratoire français de Fractionnement et de Biotechnologies at 31 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Partum Hemorrhage
- What is being tested?
- Human Fibrinogen concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 10 Apr 2014to 6 Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
France30 sites
CHU d'Angers
Angers, 49933
Hôpital Privé d'Antony
Antony, 92160
Centre Hospitalier Fleyriat
Bourg-en-Bresse, 01012
Hôpital Femme Mère Enfant
Bron, 69500
Hôpital Antoine Béclère
Clamart, 92141
CHU Estaing
Clermont-Ferrand, 63000
Hôpital Louis Mourier
Colombes, 92701
Les Hôpitaux de Chartres (Hôpital Pasteur)
Le Coudray, 28630
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Centre Hospitalier de Lens
Lens, 62307
CHU de Lille, Maternité Jeanne de Flandre
Lille, 59037
CHU de Limoges
Limoges, 87042
Hôpital de la Croix Rousse
Lyon, 69004
Hôpital Saint-Joseph / Pôle Parents - Enfants
Marseille, 13008
CHRU de Montpellier
Montpellier, 34295
Maternité Régionale Universitaire de Nancy
Nancy, 54042
Hôpital Necker - Enfants malades
Paris, 75015
Hôpital Armand Trousseau
Paris, 75571
Hôpital Cochin
Paris, 75679
Hôpital Tenon
Paris, 75970
CHU de Reims, Hôpital Maison Blanche
Reims, 51092
CHU de Rennes - Hôpital Sud
Rennes, 35203
CH Félix Guyon
Saint-Denis, Réunion, 97405
Polyclinique de l'Atlantique
Saint-Herblain, 44819
Groupe Hospitalier Sud Réunion
Saint-Pierre, Réunion, 97448
Hôpital de Hautepierre
Strasbourg, 67200
Hôpital Foch
Suresnes, 92151
Hôpital Paul de Viguier - Site Purpan
Toulouse, 31059
CHU de Tours
Tours, 37044
CH de Valenciennes
Valenciennes, 59300
About this study
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
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.
Read the detailed description
Randomised, double-blind,multicenter, placebo-controlled study
- Conditions
- Post-Partum Hemorrhage
- Being tested
- Human Fibrinogen concentrate, Placebo
- Keywords
- PPH, fibrinogen, vaginal delivery
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Fibrinogen concentrateDrug
Also called Clottafact, LFB
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
PlaceboDrug
As soon as possible and within 30 min following the start of prostaglandin infusion
| Study group | Role | What they receive |
|---|---|---|
| Human Fibrinogen concentrate | Experimental | 2 vials (200ml) / 3g intravenous Receives: Drug: Human Fibrinogen concentrate |
| Placebo | Placebo comparator | 2 vials (200ml) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
Secondary outcomes (2)
Patients With at Least Administration of 2 Units of RBCs
Considering failure as the fact of requiring at least 2 units of RBCs.
Measured: from H0 to Day 2
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.
Measured: From reference value to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start10 Apr 2014
- Primary completion6 Aug 2018
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie DUCLOY-BOUTHORS, Dr, Principal investigator, Maternité Jeanne de Flandre - 59037 LILLEFrédéric MERCIER, Pr, Study chair, Hôpital Antoine Béclère - 92140 CLAMARTAlexandre MIGNON, Pr, Study chair, Hôpital Cochin - 75014 PARISCyril HUISSOUD, Pr, Study chair, Hôpital Croix Rousse - 69004 LYONJean-Marie GROUIN, Study chair, Université de Rouen - 76100 ROUEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155725
- Sponsor's protocol ID
- FIDEL
- Other IDs
- 2013-002484-26
- Acronym
- FIDEL
- Status last verified
- Jul 2020
- First submitted
- 20 May 2014
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33713384
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02155725
- Acronym / sponsor ID
- FIDEL / FIDEL
- Conditions
- Post-Partum Hemorrhage
- Keywords
- PPH, fibrinogen, vaginal delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2014
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Posted 25 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Fibrinogen concentrate | Experimental | Drug: Human Fibrinogen concentrate2 vials (200ml) / 3g intravenous |
| Placebo | Placebo comparator | Drug: Placebo2 vials (200ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Fibrinogen concentrateAlso: Clottafact, LFBInjection as soon as possible and within 30 min following the start of prostaglandin infusion | Drug | Human Fibrinogen concentrate |
| PlaceboAs soon as possible and within 30 min following the start of prostaglandin infusion | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Patients With at Least Administration of 2 Units of RBCs
Time frame: from H0 to Day 2
Patients With Loss of at Least 4 g/dL of Hb
Time frame: From reference value to Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33713384Ducloy-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie DUCLOY-BOUTHORS, Dr principal investigator
Maternité Jeanne de Flandre - 59037 LILLE
Frédéric MERCIER, Pr study chair
Hôpital Antoine Béclère - 92140 CLAMART
Alexandre MIGNON, Pr study chair
Hôpital Cochin - 75014 PARIS
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Fibrinogen concentrate in people with Post-Partum Hemorrhage, run by Laboratoire français de Fractionnement et de Biotechnologies at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure Rate of PPH Management (time frame: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02155725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.