Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery (NCT02797119) | Clinical Trial Compass
CompletedPhase 4
Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery
France225 participantsStarted 2016-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Experimental group: Each patient
* experiencing a bleeding volume of more than 800 mL
* due to surgery or to atony uterine
* during an elective or non-emergent caesarean section
* secondary post-partum haemorrhage after caesarean section, even if CS has been emergent
* after complete information and consent signature.
* covered by social security. Reference non-hemorrhagic group: Each patient
* experiencing a bleeding volume of strictly less than 800 mL
* during an elective or emergent caesarean section
* after complete information and consent signature.
* covered by social security.
Exclusion Criteria:
Patient unable to consent (\<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as
* Hypersensibility to the product or excipient,
* Previous or ongoing arterial or venous thrombosis,
* Coagulopathy, except DIC associated with a predominant fibrinolytic profile,
* Renal failure,
* Previous seizures,
* intrathecal or intraventricular administration. Obstetrical contraindication to TA
* Severe HELLP syndrome (platelet count \<50 000/m3 or renal failure prior to the caesarean (RIFLE score\>2) Protocol related contraindication to inclusion
* Administration of TA before inclusion-Inherited haemorrhagic diseases and low molecular weight heparin within 24 hours before inclusion
* Patients who participated in a study on the efficacy of an experimental drug i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bleeding
Timeframe: between inclusion (T0) and 6 hours after inclusion (T360).