Fibrinogen in Haemorrhage of Delivery (FIDEL)

LFB

Status and phase: Completed; Phase 4

Conditions: Post-Partum Hemorrhage

Treatments: Drug: Placebo; Drug: Human Fibrinogen concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02155725

2013-002484-26 (EudraCT Number)

FIDEL

Details and patient eligibility

About

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.

Full description

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

Enrollment: 448 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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448 participants in 2 patient groups, including a placebo group

Human Fibrinogen concentrate

Experimental group

Description:

2 vials (200ml) / 3g intravenous

Treatment:

Drug: Human Fibrinogen concentrate

Placebo

Placebo Comparator group

Description:

2 vials (200ml)

Treatment:

Drug: Placebo