Fibrinogen in Haemorrhage of Delivery (NCT02155725) | Clinical Trial Compass
CompletedPhase 4
Fibrinogen in Haemorrhage of Delivery
France448 participantsStarted 2014-04-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
Failure Rate of PPH Management
Timeframe: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
Trial details
NCT IDNCT02155725
SponsorLaboratoire français de Fractionnement et de Biotechnologies