Back to results

Fibrinogen in Haemorrhage of Delivery (FIDEL)

Primary Purpose

Post-Partum Hemorrhage

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Human Fibrinogen concentrate

Placebo

About this trial

This is an interventional treatment trial for Post-Partum Hemorrhage focused on measuring PPH, fibrinogen, vaginal delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Human Fibrinogen concentrate

Placebo

Arm Description

2 vials (200ml) / 3g intravenous

2 vials (200ml)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patients With at Least Administration of 2 Units of RBCs

Considering failure as the fact of requiring at least 2 units of RBCs.

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.

Full Information

NCT ID

NCT02155725

First Posted

May 20, 2014

Last Updated

September 3, 2020

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

1. Study Identification

Unique Protocol Identification Number

NCT02155725

Brief Title

Fibrinogen in Haemorrhage of Delivery

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

April 10, 2014 (undefined)

Primary Completion Date

August 6, 2018 (Actual)

Study Completion Date

August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Partum Hemorrhage

Keywords

PPH, fibrinogen, vaginal delivery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

448 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Human Fibrinogen concentrate

Arm Type

Experimental

Arm Description

2 vials (200ml) / 3g intravenous

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 vials (200ml)

Intervention Type

Drug

Intervention Name(s)

Human Fibrinogen concentrate

Other Intervention Name(s)

Clottafact, LFB

Intervention Description

Injection as soon as possible and within 30 min following the start of prostaglandin infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

As soon as possible and within 30 min following the start of prostaglandin infusion

Primary Outcome Measure Information:

Title

Failure Rate of PPH Management

Description

Time Frame

Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration

Secondary Outcome Measure Information:

Title

Patients With at Least Administration of 2 Units of RBCs

Description

Considering failure as the fact of requiring at least 2 units of RBCs.

Time Frame

from H0 to Day 2

Title

Patients With Loss of at Least 4 g/dL of Hb

Description

Considering failure as the fact of having lost at least 4 g/dL of Hb.

Time Frame

From reference value to Day 2

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: