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

Sponsor
Clinique Saint-Luc
Study ID
NCT07740330
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Perioperative Bleeding

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral tranexamic acid — DRUG
    Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
  • Exacyl® — DRUG
    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.
  • Intravenous placebo — DRUG
    Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Oral Tranexamic Acid
    Participants receive 2 g of oral tranexamic acid as four 500 mg tablets approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
  • Active Comparator: Intravenous Tranexamic Acid
    Participants receive four matching oral placebo tablets approximately 2 hours before surgical incision, together with 1 g of intravenous tranexamic acid administered at induction or incision according to the study protocol.

Primary Outcome Measure

Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL) [ Time Frame: From completion of surgery to 24 hours postoperatively ]

Central Contacts

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