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Could a pill replace an IV to cut bleeding in heart surgery?

NCT ID NCT07740330

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial compares two ways of giving tranexamic acid, a drug that reduces bleeding, to adults undergoing off-pump coronary artery bypass surgery. Half receive the drug as a pill before surgery, while the other half get it through an IV during surgery. The goal is to see if the oral form is just as effective at limiting blood loss after surgery, which could make treatment simpler and more affordable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid (oral and intravenous formulations)
What this could lead to
If oral tranexamic acid works as well as the IV form, it could offer a simpler, cheaper way to reduce bleeding during heart bypass surgery.
What could go wrong
This is a single trial with 160 participants, and non-inferiority doesn't guarantee equal effectiveness. There are also risks like blood clots or seizures, though rare.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 years or older. 2. 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. 3. 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. 4. Written informed consent obtained before randomization. 5. Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery. 6. Available for in-hospital follow-up and Day 30 assessment. Exclusion Criteria: 1. Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting. 2. Inability to provide informed consent or comply with the required follow-up. 3. Hypersensitivity to tranexamic acid or any excipient of the study products. 4. 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. 5. Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis. 6. Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access. 7. Pregnancy or breastfeeding. 8. Participation in another interventional clinical trial that could interfere with study outcomes or safety. 9. Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid. 10. Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe. 11. Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Postoperative Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinique Saint-Luc

    Bouge, Namur, 5004, Belgium

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