This trial explores whether a goal-directed strategy for tranexamic acid (TXA) administration, guided by rotational thromboelastometry (ROTEM), is as effective as preemptive TXA administration in reducing postoperative bleeding in cardiovascular surgery. TXA is widely used to mitigate surgical bleeding, but its administration can lead to complications like seizures and thromboembolic events, especially in patients with fibrinolysis shutdown.
The GDT trial is a multi-center, double-blind, placebo-controlled, randomized, parallel-group study. It involves 764 patients undergoing elective cardiovascular surgery across three tertiary hospitals in South Korea. Patients are randomized into two groups:
- Group-P: Preemptive TXA administration (10 mg/kg bolus and 2 mg/kg/h infusion).
- Group-GDT: TXA or placebo is administered based on ROTEM findings (20 mg/kg bolus for patients with specific fibrinolysis profiles).
The primary outcome is the volume of postoperative bleeding in the first 24 hours. Secondary outcomes include perioperative transfusion rates, coagulation profiles, reoperation rates, thromboembolic events, seizures, hospital costs, and mortality.
Rationale
Preemptive TXA is effective but carries risks, including thromboembolic complications and seizures. A goal-directed approach using ROTEM may reduce these risks by tailoring TXA use to the patient’s fibrinolysis phenotype, avoiding unnecessary administration in patients with fibrinolysis shutdown.
Methods
ROTEM tests are conducted at three points:
1.After anesthesia induction.
2.Before weaning from cardiopulmonary bypass (CPB).
3.At the end of surgery.
Group-P receives TXA regardless of ROTEM results, while Group-GDT receives TXA or placebo based on specific ROTEM thresholds. Open-label TXA use is allowed for severe bleeding, with the decision recorded.
Anticipated Results
The hypothesis suggests that goal-directed TXA use will be non-inferior in reducing bleeding while lowering adverse events like thromboembolic complications and seizures.
Clinical Implications
This study has the potential to redefine TXA administration strategies in high-risk surgeries, optimizing efficacy while minimizing complications.
