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

NCT07740330 | Not Yet Recruiting Phase 4

• 2 other identifiers: TRANSCAB2026-526581-24-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Perioperative Bleeding

Keywords

Tranexamic Acid; Off-Pump Coronary Artery Bypass Grafting; OPCAB; Oral Administration; Intravenous Administration; Postoperative Blood Loss; Cardiac Surgery; Non-Inferiority Trial

Outcome Measures

Primary Outcomes (1)

• Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)

  Total cumulative volume of blood collected from mediastinal and pleural chest drains during the first 24 hours after completion of surgery, expressed in milliliters.

  From completion of surgery to 24 hours postoperatively

Secondary Outcomes (9)

• Number of Participants Receiving Red Blood Cell Transfusion

  From surgery until hospital discharge, up to 30 days

• Hemoglobin Concentration at 24 Hours After Surgery (g/dL)

  At 24 hours after surgery

• Number of Participants Requiring Reoperation for Bleeding

  During the index hospitalization, up to 30 days

• Number of Participants With Thromboembolic Events

  From study intervention until 30 days after surgery

• Number of Participants With Postoperative Seizures

  During the index hospitalization, up to 30 days

Study Arms (2)

Oral Tranexamic Acid

EXPERIMENTAL

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.

Drug: Oral tranexamic acid; Drug: Intravenous placebo

Intravenous Tranexamic Acid

ACTIVE COMPARATOR

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.

Drug: Exacyl®

Interventions

Oral tranexamic acid DRUG

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

Oral Tranexamic Acid

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 Tranexamic Acid

Intravenous placebo DRUG

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

Oral Tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Elective isolated coronary artery bypass grafting planned without cardiopulmonary bypass, including off-pump coronary artery bypass through sternotomy or minimally invasive/direct or totally endoscopic coronary artery bypass surgery. Conversion to cardiopulmonary bypass is permitted if clinically required.
• Perioperative tranexamic acid planned as part of routine care, with the participant eligible for both oral and intravenous administration according to the applicable product information and local policy.
• Written informed consent obtained before randomization.
• Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery.
• Available for in-hospital follow-up and Day 30 assessment.

You may not qualify if:

• Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.
• Inability to provide informed consent or comply with the required follow-up.
• Hypersensitivity to tranexamic acid or any excipient of the study products.
• Contraindication or clinically relevant precaution to tranexamic acid according to the applicable product information, including:
• active arterial or venous thromboembolic disease or active intravascular clotting;
• history of subarachnoid hemorrhage;
• acquired defective color vision;
• clinically relevant seizure disorder or previous tranexamic-acid-associated seizure;
• disseminated intravascular coagulation without predominant hyperfibrinolysis;
• active upper urinary tract hematuria with a risk of ureteric obstruction.
• Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
• Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access.
• Pregnancy or breastfeeding.
• Participation in another interventional clinical trial that could interfere with study outcomes or safety.
• Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid.

Sponsors & Collaborators

• Clinique Saint-Luc: lead

Study Sites (1)

Clinique Saint-Luc

Bouge, Namur, 5004, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease; Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Benjamin Javillier, MD

  Clinique Saint-Luc Bouge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Javillier, MD

CONTACT

081 20 91 55; benjamin.javillier@slbo.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-dummy design is used. Participants receive either oral tranexamic acid and intravenous placebo or oral placebo and intravenous tranexamic acid. Participants, perioperative care providers, investigators, and outcome assessors are unaware of treatment allocation. The randomization list is held by the hospital pharmacy, with emergency unblinding available according to the protocol.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized in a 1:1 ratio to two parallel groups comparing oral tranexamic acid with intravenous tranexamic acid using a double-dummy design.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 12 months after publication of the primary results and available for 5 years.
• Access Criteria: Access may be granted to qualified researchers whose proposed use of the data has been approved by the Sponsor. Requests must include a scientifically sound research proposal and will require a signed data use or data transfer agreement. Data will be shared only in accordance with applicable data-protection, ethical, and regulatory requirements.

Locations

BE (1)