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COMPLETED
NCT02797119
PHASE4

Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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.

Official title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

225

Start Date

2016-03-15

Completion Date

2021-04-15

Last Updated

2026-04-21

Healthy Volunteers

Yes

Interventions

DRUG

tranexamic acid 1 g (TA1)

1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute

DRUG

tranexamic acid 0.5 g (TA1/2)

0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute

DRUG

Saline Solution (TA0)

Locations (5)

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Hospices civils de Lyon CHU-Lyon Croix Rousse

Lyon, France

Assistance Publique Hôpitaux Paris Hôpital Louis Mourier

Paris, France

Assistance Publique Hôpitaux Paris Hôpital Trousseau

Paris, France

Centre Hospitalier Maternité Monaco Valenciennes

Valenciennes, France