Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint-Luc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
active arterial or venous thromboembolic disease or active intravascular clotting;
Trial design
Design model
Parallel
Treatments tested in this trial
Oral tranexamic acid
DrugTranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
Exacyl®
DrugTranexamic 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
DrugIntravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Oral Tranexamic AcidExperimental treatment 2 interventions
Group B: Intravenous Tranexamic AcidActive comparator 1 intervention
Trial outcomes
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.
Time frame
From completion of surgery to 24 hours postoperativelySecondary outcomes
1
Number of Participants Receiving Red Blood Cell Transfusion
Number and proportion of participants receiving at least one unit of packed red blood cells during surgery or the postoperative hospital stay, and the total number of units transfused per participant.
Time frame
From surgery until hospital discharge, up to 30 days2
Hemoglobin Concentration at 24 Hours After Surgery (g/dL)
Hemoglobin concentration measured from routine postoperative blood samples, expressed in grams per deciliter.
Time frame
At 24 hours after surgery3
Number of Participants Requiring Reoperation for Bleeding
Number and proportion of participants requiring surgical re-exploration because of postoperative bleeding or cardiac tamponade.
Time frame
During the index hospitalization, up to 30 days4
Number of Participants With Thromboembolic Events
Occurrence of clinically diagnosed arterial or venous thromboembolic events, including myocardial infarction, ischemic stroke, deep vein thrombosis, or pulmonary embolism.
Time frame
From study intervention until 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov
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