Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: French Health Products Safety Agency; Ministry of Health, France
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

Experimental group: Each patient

• experiencing a bleeding volume of more than 800 mL

• due to surgery or to atony uterine

• during an elective or non-emergent caesarean section

• secondary post-partum haemorrhage after caesarean section, even if CS has been emergent

• after complete information and consent signature.

• covered by social security. Reference non-hemorrhagic group: Each patient

• experiencing a bleeding volume of strictly less than 800 mL

• during an elective or emergent caesarean section

• after complete information and consent signature.

• covered by social security.

Exclusion Criteria:

Patient unable to consent (<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as

• Hypersensibility to the product or excipient,

• Previous or ongoing arterial or venous thrombosis,

• Coagulopathy, except DIC associated with a predominant fibrinolytic profile,

• Renal failure,

• Previous seizures,

• intrathecal or intraventricular administration. Obstetrical contraindication to TA

• Severe HELLP syndrome (platelet count <50 000/m3 or renal failure prior to the caesarean (RIFLE score>2) Protocol related contraindication to inclusion

• Administration of TA before inclusion-Inherited haemorrhagic diseases and low molecular weight heparin within 24 hours before inclusion

• Patients who participated in a study on the efficacy of an experimental drug in the two month preceding the caesarean section

• Inherited haemorrhagic diseases or low molecular weight heparin within 24 hours before inclusion

• Previous inclusion in an interventional trial since the 2 months before CS