AuthorisedTherapeutic use (Phase IV)Interventional

Oral versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomised Non-Inferiority Trial (TRANSCAB Study)

Heart bypass surgery helps restore normal blood flow to the heart. During this type of major operation, blood loss is common. Doctors routinely use a medicine called tranexamic acid to help blood clot normally and reduce the need for blood transfusions. Usually, this medicine is given directly into a vein through an intravenous drip. The TRANSCAB study is testing whether taking tranexamic acid as a tablet before surgery is just as effective and safe as using a drip. Researchers will measure bleeding through chest drains in the first 24 to 48 hours after surgery. They will also look at whether patients need blood transfusions, how quickly they recover, and monitor their safety for 30 days. If the tablets work just as well, it could make treatment simpler and cheaper for hospitals.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Sante et Prevoyance

Enrolment target

160

Start

06 Jul 2026

Coronary artery disease requiring off-pump coronary artery bypass surgery (OPCAB)

What is this study about?

Coronary artery bypass surgery is an operation used to treat blocked or narrowed heart arteries. In 'off-pump' bypass surgery, the surgeon operates while the heart is still beating, without using a heart-lung bypass machine. As with any major surgery, managing blood loss is very important. Preventing bleeding helps patients recover faster and reduces the need for blood transfusions.

Tranexamic acid is an established medicine used worldwide to help blood clot and stop bleeding. Currently, most surgical teams give this medicine through a drip directly into a vein. However, tranexamic acid also comes in tablet form. Researchers want to find out whether swallowing tablets before surgery works just as well at controlling bleeding as the standard drip.

This study is a 'non-inferiority' trial, which means researchers are checking that the tablet is not worse than the drip. If swallowing tablets provides the same protection, it could simplify surgical care, reduce equipment needs, and cut costs for the NHS, all while keeping patient care at the highest standard.

Key takeaways

Compares tranexamic acid tablets with a standard intravenous drip.
Aims to safely reduce bleeding during off-pump heart bypass surgery.
Every participant receives the active clotting medicine.
Doctors will measure blood loss, recovery times, and track safety for 30 days.
Participation is completely voluntary and will not delay your surgery.

Who may be eligible?

This trial is open to adults aged 18 and older who are scheduled to have an off-pump coronary artery bypass operation. Both men and women can take part.

Because this study specifically focuses on operations performed on a beating heart, people having traditional bypass surgery using a heart-lung machine cannot join. Your surgical team can tell you which type of bypass operation you are having.

Before you can join, doctors will review your general health, medical history, and kidney function to ensure that tranexamic acid is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have coronary artery disease.
I am scheduled to have off-pump coronary artery bypass surgery.
I am happy to take my study medicine as either a tablet or a drip.
I agree to follow-up checks for 30 days after my surgery.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly placed into one of two groups by a computer. One group will take tranexamic acid tablets by mouth, and the other group will receive tranexamic acid through a standard drip into a vein. Neither you nor your doctor can choose your group, but everyone receives the active medicine. The treatment is given around the time of your planned surgery. While you recover in hospital, nurses and doctors will measure the fluid from your chest drains, take routine blood tests, and track your healing. The research team will monitor your progress until 30 days after your operation to make sure you have recovered safely.

Potential risks and benefits

A potential benefit of joining is receiving a well-known, effective medicine to reduce bleeding, while helping doctors discover simpler ways to treat future heart surgery patients. Tranexamic acid is widely used and generally safe, but like all medicines, it can sometimes cause side effects such as nausea, or very rarely, blood clots or seizures. The hospital team will monitor you closely in the intensive care unit and surgical ward. Taking part is completely voluntary. You are free to change your mind and withdraw at any time, and this will not affect the quality of your NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

Will I receive a dummy drug (placebo)?

No. Everyone taking part receives tranexamic acid. You will receive it either as a tablet to swallow or as a drip into a vein.

What does 'off-pump' heart surgery mean?

It means the surgeon performs the bypass while your heart is still beating naturally, without connecting you to a heart-lung bypass machine.

Will taking part delay my operation?

No. The trial is scheduled around your planned surgery and will not delay your procedure.

How long will I be in the study?

You receive the medicine on the day of your surgery, and the team will follow your progress while you are in hospital and up to 30 days afterwards.

Can I leave the trial if I change my mind?

Yes, you can leave the study at any point without giving a reason, and your medical care will not be affected in any way.