Oral versus intravenous tranexamic acid to reduce bleeding in patients undergoing off‑pump coronary artery bypass surgery

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What is this study about?

The study focuses on patients with Coronary artery disease who need a type of heart operation called off-pump coronary artery bypass surgery. To help reduce bleeding during and after the operation, the medication tranexamic acid is being given either as a pill taken by mouth (oral) or as a medicine given through a vein (intravenous).

The main goal is to see whether the pill form works at least as well as the vein form in lowering the amount of blood that drains from the chest in the first day after surgery. Participants will receive the assigned form of the drug before the operation and will be monitored for blood loss, need for blood transfusion, and other safety checks during the hospital stay.

After the surgery, the amount of fluid collected from chest tubes will be measured for 24 hours, and patients will stay in the intensive care unit and then the regular hospital ward while doctors watch for any complications such as kidney problems or clotting events. The study will follow each participant for about a month after the operation to record any further issues.

1 enrollment and randomization

after agreeing to take part, you are assigned to one of two groups by a computer system.

the assignment determines whether you will receive oral or intravenous tranexamic acid.

2 pre‑operative medication

if assigned to the oral group, you take four 500 mg film‑coated tablets (total 2000 mg) by mouth shortly before the operation.

if assigned to the intravenous group, a nurse injects a solution containing 1000 mg of tranexamic acid into a vein shortly before the operation.

3 surgery

you undergo off‑pump coronary artery bypass surgery, a heart procedure performed without a heart‑lung machine.

4 post‑operative monitoring (first 24 hours)

chest‑tube drainage is measured continuously; the total volume collected during the first 24 hours is recorded.

blood tests are taken to check haemoglobin levels and kidney function.

if needed, red‑blood‑cell transfusions are given according to pre‑defined criteria.

5 post‑operative monitoring (24‑48 hours)

chest‑tube output is measured at 12 hours and at 24 hours.

the chest tube is removed when drainage is low, and the time to removal is recorded.

6 hospital stay and discharge

you remain in the intensive care unit until stable, then move to a regular ward.

the length of stay in the intensive care unit and the total hospital stay are recorded.

7 follow‑up period (up to day 30)

you are monitored for any bleeding complications, need for additional surgery, or thromboembolic events such as heart attack, stroke, deep‑vein thrombosis, or pulmonary embolism.

you are also observed for seizures, kidney injury, and overall survival up to 30 days after surgery.

Who Can Join the Study?

Be an adult (age 18 years or older).
Have a planned, non‑emergency (elective) heart surgery called coronary artery bypass that will be done without using a heart‑lung machine (off‑pump coronary artery bypass surgery (OPCAB)); the surgery must be either the standard open‑chest method (median sternotomy) or a less invasive side‑incision method (MIDCAB).
Be expected to receive the medication tranexamic acid around the time of surgery to help reduce bleeding, and you must be able to take it either by mouth (oral) or through a vein (intravenous) with no reason that one route is unsafe for you.
Provide a signed written informed consent agreeing to join the study before you are placed into a treatment group by randomisation.

Who Cannot Join the Study?

If the heart bypass surgery (called coronary artery bypass graft (CABG)) is an emergency, is combined with other procedures, or is planned to use a heart‑lung machine (known as “on‑pump” surgery) instead of the off‑pump method, you cannot join the study.
If you are unable to give permission to take part (known as informed consent) or cannot attend the required hospital visits during your stay and for 30 days after the operation.
If you have a known hypersensitivity (allergy) to tranexamic acid or to any of the inactive ingredients (called excipients) in the medication.
If you have any condition that makes using tranexamic acid unsafe, such as ongoing blood clots inside vessels (active intravascular clotting), a serious brain bleed called subarachnoid hemorrhage, loss of color vision (acquired defective colour vision), or a history of seizures or epilepsy that were linked to the drug.
If you have severe kidney problems (renal impairment) measured as an eGFR below 30 mL/min/1.73 m², or if you are undergoing regular kidney cleaning treatment (dialysis).
If you cannot take medicines by mouth because you cannot swallow a tablet, have a condition that prevents your gut from absorbing medicines (called malabsorption or after removal of part of the stomach, post‑gastrectomy), or if it is impossible to place an IV line (IV access) for medication.
If you are pregnant, breastfeeding, or could become pregnant and have not had a recent negative pregnancy test according to local practice.
If you are already taking part in another study that tests a drug or medical device and could affect the results or safety of this trial.
If you plan to use another medicine that reduces bleeding (antifibrinolytic) such as aprotinin or ε‑aminocaproic acid outside of the study’s medication schedule.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Scact eu Peadnnajxm	Namur	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.07.2026

Trial locations

Investigated Drugs:

Tranexamic Acid

Tranexamic acid (oral tablets) is a medicine taken by mouth in tablet form. In this study it is the test treatment. The tablets are designed to be swallowed before or during surgery to help the blood clot more quickly, which can reduce the amount of bleeding after the heart operation. By giving the drug this way, researchers want to see if it works as well as the injection form in keeping blood loss low.

Tranexamic acid (intravenous solution) is the same medicine but given through a needle into a vein. In the trial it serves as the comparator treatment. The injection is administered during the coronary artery bypass surgery to help the blood clot and limit bleeding from the surgical site. The study compares this standard method with the oral tablets to find out if the tablets are just as effective at preventing blood loss.

Investigated Diseases:

Coronary artery disease requiring off-pump coronary artery bypass surgery (OPCAB) – It is a narrowing of the arteries that supply the heart muscle, leading to reduced blood flow. Over time, the blockage can cause chest discomfort, shortness of breath, or fatigue during activity. When the narrowing is significant, surgeons may perform an off‑pump coronary artery bypass, which creates new pathways for blood without using a heart‑lung machine. The condition tends to worsen gradually as plaque builds up, increasing the demand on the heart. Symptoms may become more frequent as the disease progresses.

Trial ID:

2026-526581-24-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Oral versus intravenous tranexamic acid to reduce bleeding in patients undergoing off‑pump coronary artery bypass surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?