Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot… (NCT06622564) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial
Canada40 participantsStarted 2025-01-01
Plain-language summary
The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery. The main questions it aims to answer are:
* Is it feasible to conduct a larger definitive trial?
* Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples?
Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better.
Participants will:
* Provide written informed consent
* Receive tranexamic acid during surgery
* Provide blood samples at 5 time points: before surgery, on arrival in intensive care unit, 3 hours after arrival, 6 hours after arrival, and on the next morning.
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥18 years of age
✓. Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass
✓. Provide written informed consent
Exclusion criteria
✕. Allergy to tranexamic acid
✕. Fulfill any of the following transfusion risk factors (A-F):
✕. Estimated glomerular filtration rate \<30 mL/min (CKD-EPI equation) or on dialysis
✕. Pre-operative hemoglobin \>170 g/L
✕. Expected circulatory arrest
✕. Pregnancy or breast feeding
✕. Previous enrollment in DEPOSITION trial
✕
What they're measuring
1
Measure the level of plasma TxA at 5 time points
Timeframe: From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.