Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
University Hospital, Lille
Collaborators:
French Health Products Safety Agency Ministry of Health, France