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Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery
Sponsor: University Hospital, Lille
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
Conditions
Interventions
tranexamic acid 1 g (TA1)
1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
tranexamic acid 0.5 g (TA1/2)
0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
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