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Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery

NCT02797119 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • French Health Products Safety Agency

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Anne-Sophie Ducloy-Bouthors, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-15
Primary Completion
2021-04-15
Completion
2021-04-15

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02797119 on ClinicalTrials.gov