drugset / Trial / NCT06622564

Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial

NCT06622564

Phase 3 Not yet recruiting 40 enrolled Hamilton Health Sciences Corporation
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-01-01
Primary completion
2026-01-01
Completion
2026-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 1 g Intravenous
Comparator Tranexamic Acid Small molecule 5 g Intravenous
Comparator Tranexamic Acid Small molecule 10 g Intravenous