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Oral versus intravenous tranexamic acid to reduce bleeding during off-pump heart bypass surgery (TRANSCAB)
EU CTIS ID: 2026-526581-24-01
What this study is testing
To demonstrate non-inferiority of oral tranexamic acid compared with intravenous tranexamic acid in reducing postoperative blood loss within 24 hours after off-pump coronary artery bypass surgery, measured by chest-tube drainage volume.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥18 years
- Elective, isolated coronary artery bypass surgery planned without CPB — either OPCAB (median sternotomy) or MIDCAB
- Peri-operative tranexamic acid is planned as part of routine care; the patient is eligible to receive TXA by both oral and intravenous routes (no route-specific contraindication)
- Written informed consent obtained before randomisation
You likely can't join if
- Emergency or non-isolated CABG (combined procedures other than OPCAB/MIDCAB); planned on-pump CABG
- Inability to provide informed consent or to comply with in-hospital/30-day follow-up
- Known hypersensitivity to tranexamic acid or excipients
- Contraindication to TXA per SmPC, including: active intravascular clotting/consumptive coagulopathy; history of subarachnoid haemorrhage; acquired defective colour vision; history of TXA-associated seizures or epilepsy/seizure disorder requiring treatment
- Severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis
- Contraindication to either administration route: e.g., inability to swallow a tablet or significant malabsorption/post-gastrectomy precluding oral dosing; or IV access impossible
See the full eligibility criteria
- Adults ≥18 years
- Elective, isolated coronary artery bypass surgery planned without CPB — either OPCAB (median sternotomy) or MIDCAB
- Peri-operative tranexamic acid is planned as part of routine care; the patient is eligible to receive TXA by both oral and intravenous routes (no route-specific contraindication)
- Written informed consent obtained before randomisation
- Emergency or non-isolated CABG (combined procedures other than OPCAB/MIDCAB); planned on-pump CABG
- Inability to provide informed consent or to comply with in-hospital/30-day follow-up
- Known hypersensitivity to tranexamic acid or excipients
- Contraindication to TXA per SmPC, including: active intravascular clotting/consumptive coagulopathy; history of subarachnoid haemorrhage; acquired defective colour vision; history of TXA-associated seizures or epilepsy/seizure disorder requiring treatment
- Severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis
- Contraindication to either administration route: e.g., inability to swallow a tablet or significant malabsorption/post-gastrectomy precluding oral dosing; or IV access impossible
- Pregnancy or breastfeeding (women of child-bearing potential without a negative test per local practice are excluded)
- Concomitant participation in another interventional drug/device trial that could interfere with outcomes or safety
- Planned use of another antifibrinolytic (e.g., aprotinin, ε-aminocaproic acid) outside the trial regimen
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.