Coronary Artery DiseasePhase 4TRANSCABNCT07740330
Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery
A Phase 4 study testing Oral tranexamic acid and Exacyl® in people with Coronary Artery Disease and Perioperative Bleeding, run by Clinique Saint-Luc at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Perioperative Bleeding
- What is being tested?
- Oral tranexamic acid and Exacyl®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
- Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.
- Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Clinique Saint-Luc
Bouge, Namur, 5004
Benjamin Javillier, MD, 081209155 ext. +32, benjamin.javillier@slbo.be
About this study
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
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.
Read the detailed description
Perioperative bleeding remains an important complication of coronary artery bypass surgery and may lead to blood transfusion, reoperation, prolonged hospitalization, and increased postoperative morbidity. Tranexamic acid is an antifibrinolytic drug widely used in cardiac surgery to reduce bleeding and transfusion requirements. It is most commonly administered intravenously, although oral administration may provide adequate systemic exposure while simplifying drug preparation and administration.
TRANSCAB is a monocentric, prospective, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority trial conducted in adult patients undergoing elective off-pump coronary artery bypass grafting.
A total of 160 participants will be randomized in a 1:1 ratio to one of two treatment groups:
- Oral tranexamic acid group: four 500 mg tranexamic acid tablets administered approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
- Intravenous tranexamic acid group: four matching oral placebo tablets administered approximately 2 hours before surgical incision, together with 1 g intravenous tranexamic acid administered at induction or incision according to the study protocol.
Participants, clinicians involved in perioperative management, outcome assessors, and investigators will remain blinded to treatment allocation. Study treatments will be prepared and dispensed according to the randomization list by the hospital pharmacy.
The primary objective is to assess whether oral tranexamic acid is non-inferior to intravenous tranexamic acid in reducing postoperative blood loss following off-pump coronary artery bypass grafting.
Secondary and safety outcomes will assess perioperative transfusion requirements, postoperative hemoglobin changes, clinically significant bleeding, reoperation for bleeding, thromboembolic events, seizures, acute kidney injury, mortality, duration of intensive care and hospital stay, and other postoperative complications specified in the protocol.
- Conditions
- Coronary Artery Disease, Perioperative Bleeding
- Being tested
- Oral tranexamic acid, Exacyl®, Intravenous placebo
- Keywords
- Tranexamic Acid, Off-Pump Coronary Artery Bypass Grafting, OPCAB, Oral Administration, Intravenous Administration, Postoperative Blood Loss, Cardiac Surgery, Non-Inferiority Trial
- Medical subject headings
- Coronary Artery Disease, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tranexamic acidDrug
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 placeboDrug
Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Exacyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From completion of surgery to 24 hours postoperatively
Secondary outcomes (9)
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.
Measured: From surgery until hospital discharge, up to 30 days
Hemoglobin Concentration at 24 Hours After Surgery (g/dL)
Hemoglobin concentration measured from routine postoperative blood samples, expressed in grams per deciliter.
Measured: At 24 hours after surgery
Number of Participants Requiring Reoperation for Bleeding
Number and proportion of participants requiring surgical re-exploration because of postoperative bleeding or cardiac tamponade.
Measured: During the index hospitalization, up to 30 days
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.
Measured: From study intervention until 30 days after surgery
Number of Participants With Postoperative Seizures
Occurrence of clinically diagnosed postoperative seizures.
Measured: During the index hospitalization, up to 30 days
Number of Participants With Acute Kidney Injury According to Kidney Disease: Improving Global Outcomes (KDIGO) Criteria
Number of participants with postoperative acute kidney injury classified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria (Stages 1, 2, or 3).
Measured: Within 7 days after surgery or until hospital discharge, whichever occurs first
Number of Participants With All-Cause Mortality Within 30 Days After Surgery
Death from any cause.
Measured: Within 30 days after surgery
Length of Intensive Care Unit Stay (days)
Duration of the postoperative intensive care unit stay, expressed in hours or days.
Measured: From intensive care unit admission until discharge from the intensive care unit, up to 30 days
Length of Hospital Stay (days)
Duration of the postoperative hospital stay, expressed in days.
Measured: From the date of surgery until hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Luc
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Benjamin JAVILLIER, Clinique Saint-Luc
- Investigators
- Benjamin Javillier, MD, Principal investigator, Clinique Saint-Luc Bouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740330
- Sponsor's protocol ID
- TRANSCAB
- Other IDs
- 2026-526581-24-01
- Acronym
- TRANSCAB
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the Sponsor and Coordinating Investigator and will require an approved research proposal and a signed data use or data transfer agreement. Data sharing will be subject to applicable ethical, legal, regulatory, and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07740330
- Acronym / sponsor ID
- TRANSCAB / TRANSCAB
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Clinique Saint-LucResearch network
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Perioperative bleeding remains an important complication of coronary artery bypass surgery and may lead to blood transfusion, reoperation, prolonged hospitalization, and increased postoperative morbidity. Tranexamic acid is an antifibrinolytic drug widely used in cardiac surgery to reduce bleeding and transfusion requirements. It is most commonly administered intravenously, although oral administration may provide adequate systemic exposure while simplifying drug preparation and administration.
TRANSCAB is a monocentric, prospective, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority trial conducted in adult patients undergoing elective off-pump coronary artery bypass grafting.
A total of 160 participants will be randomized in a 1:1 ratio to one of two treatment groups:
- Oral tranexamic acid group: four 500 mg tranexamic acid tablets administered approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
- Intravenous tranexamic acid group: four matching oral placebo tablets administered approximately 2 hours before surgical incision, together with 1 g intravenous tranexamic acid administered at induction or incision according to the study protocol.
Participants, clinicians involved in perioperative management, outcome assessors, and investigators will remain blinded to treatment allocation. Study treatments will be prepared and dispensed according to the randomization list by the hospital pharmacy.
The primary objective is to assess whether oral tranexamic acid is non-inferior to intravenous tranexamic acid in reducing postoperative blood loss following off-pump coronary artery bypass grafting.
Secondary and safety outcomes will assess perioperative transfusion requirements, postoperative hemoglobin changes, clinically significant bleeding, reoperation for bleeding, thromboembolic events, seizures, acute kidney injury, mortality, duration of intensive care and hospital stay, and other postoperative complications specified in the protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral Tranexamic Acid | Experimental | Drug: Oral tranexamic acid, Drug: Intravenous placeboParticipants 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. |
| Intravenous Tranexamic Acid | Active comparator | Drug: Exacyl®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral tranexamic acidTranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision. | Drug | Oral Tranexamic Acid |
| 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 Tranexamic Acid |
| Intravenous placeboIntravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol. | Drug | Oral Tranexamic Acid |
Primary outcome
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
Time frame: From completion of surgery to 24 hours postoperatively
Total cumulative volume of blood collected from mediastinal and pleural chest drains during the first 24 hours after completion of surgery, expressed in milliliters.
9 secondary outcomes
Number of Participants Receiving Red Blood Cell Transfusion
Time frame: From surgery until hospital discharge, up to 30 days
Hemoglobin Concentration at 24 Hours After Surgery (g/dL)
Time frame: At 24 hours after surgery
Number of Participants Requiring Reoperation for Bleeding
Time frame: During the index hospitalization, up to 30 days
Number of Participants With Thromboembolic Events
Time frame: From study intervention until 30 days after surgery
Number of Participants With Postoperative Seizures
Time frame: During the index hospitalization, up to 30 days
Number of Participants With Acute Kidney Injury According to Kidney Disease: Improving Global Outcomes (KDIGO) Criteria
Time frame: Within 7 days after surgery or until hospital discharge, whichever occurs first
Number of Participants With All-Cause Mortality Within 30 Days After Surgery
Time frame: Within 30 days after surgery
Length of Intensive Care Unit Stay (days)
Time frame: From intensive care unit admission until discharge from the intensive care unit, up to 30 days
Length of Hospital Stay (days)
Time frame: From the date of surgery until hospital discharge, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the Sponsor and Coordinating Investigator and will require an approved research proposal and a signed data use or data transfer agreement. Data sharing will be subject to applicable ethical, legal, regulatory, and data-protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Javillier, MD principal investigator
Clinique Saint-Luc Bouge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral tranexamic acid and Exacyl® in people with Coronary Artery Disease and Perioperative Bleeding, run by Clinique Saint-Luc at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, MD (081 20 91 55 ext. +32, benjamin.javillier@slbo.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL) (time frame: From completion of surgery to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.