At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating tranexamic acid 1 g (TA1), tranexamic acid 0.5 g (TA1/2), and 1 other intervention for Pregnancy Complications and Hemorrhage. Completed, enrolled 225 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute