Could a pill replace an IV to cut bleeding in heart surgery?
NCT ID NCT07740330
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Clinique Saint-Luc
Bouge, Namur, 5004, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New heart scan aims to spot hidden plaque before it strikes
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?