Study to determine tranxamic acid's effect on the bleedings that occurs within the haemorrhagic caesarea

Phase 1

• Conditions: Haemorrhagic ceaserean; MedDRA version: 18.1Level: LLTClassification code 10036418Term: Postpartum hemorrhageSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-002499-26-FR
• Lead Sponsor: Centre Hospitalier Régional et Universitaire de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-08
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 342

Inclusion Criteria

-Each patient experiencing a bleeding volume of more than 800 mL during an elective or emergent caesarean section
-Patient covered by social security

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patient unable to consent and/or <18 years old and/or legally assisted (incapable people or specially protected mentioned on the article L1121-5 to L1121-8 will not be included in the study).
•Previous deep vein thrombosis or seizures or any contraindication to tranexamic acid
•Inherited haemorrhagic diseases, essentially the Von Willbebrand disease
•Patient presenting with a severe Hellp syndrome (platelet count <50 000/m3) or renal failure prior to the caesarean section (RIFLE score>2)
•Administration of TA before inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified