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NOT YET RECRUITING
NCT07740330
PHASE4

Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery

Sponsor: Clinique Saint-Luc

View on ClinicalTrials.gov

Summary

Tranexamic acid is commonly administered intravenously during cardiac surgery to reduce perioperative bleeding. Oral tranexamic acid may offer a simpler and less costly alternative, but its effectiveness in patients undergoing off-pump coronary artery bypass grafting has not been adequately established. TRANSCAB is a randomized, double-blind, parallel-group, non-inferiority clinical trial comparing oral and intravenous tranexamic acid in adults undergoing elective off-pump coronary artery bypass grafting. Participants will receive either oral tranexamic acid before surgery with an intravenous placebo at induction, or oral placebo before surgery with intravenous tranexamic acid at induction. The primary objective is to determine whether oral tranexamic acid is non-inferior to intravenous tranexamic acid for reducing postoperative blood loss. Secondary objectives include comparing transfusion requirements, postoperative hemoglobin levels, reoperation for bleeding, thromboembolic complications, seizures, acute kidney injury, and other postoperative outcomes.

Official title: Oral Versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomized Double-Blind Non-Inferiority Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-10

Completion Date

2028-07

Last Updated

2026-07-31

Healthy Volunteers

No

Interventions

DRUG

Oral tranexamic acid

Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.

DRUG

Exacyl®

Tranexamic acid, 1 g intravenously, diluted in 0.9% sodium chloride to a total volume of 50 mL and administered at induction or incision according to the study protocol.

DRUG

Intravenous placebo

Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.

Locations (1)

Clinique Saint-Luc

Bouge, Namur, Belgium