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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526581-24-01
Enrollment
160
Registered
2026-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

Cumulative postoperative chest-tube drainage within 24 hours after surgery (mL).

Detailed description

Allogeneic red-blood-cell (RBC) transfusion (yes/no), Number of RBC units transfused, Calculated blood loss at 24 h (mL), Calculated blood loss at 48 h (mL), Intraoperative blood loss (mL), Chest-drain output at 12 h (mL), Time to chest-drain removal (hours), Postoperative haemoglobin at 24 h (g/dL), Nadir haemoglobin during index admission (g/dL), ICU length of stay (hours), Hospital length of stay (days), Re-exploration for bleeding within 48 h (yes/no), Thromboembolic events up to day 30 (composite: MI, ischaemic stroke/TIA, DVT, PE), Seizures up to day 30 (yes/no), Acute kidney injury (KDIGO) during index admission (any stage), All-cause mortality by day 30

Interventions

DRUGTranexamic acid Tillomed 500 mg film-coated tablets

Sponsors

Sante et Prevoyance
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Cumulative postoperative chest-tube drainage within 24 hours after surgery (mL).

Secondary

MeasureTime frame
Allogeneic red-blood-cell (RBC) transfusion (yes/no), Number of RBC units transfused, Calculated blood loss at 24 h (mL), Calculated blood loss at 48 h (mL), Intraoperative blood loss (mL), Chest-drain output at 12 h (mL), Time to chest-drain removal (hours), Postoperative haemoglobin at 24 h (g/dL), Nadir haemoglobin during index admission (g/dL), ICU length of stay (hours), Hospital length of stay (days), Re-exploration for bleeding within 48 h (yes/no), Thromboembolic events up to day 30 (composite: MI, ischaemic stroke/TIA, DVT, PE), Seizures up to day 30 (yes/no), Acute kidney injury (KDIGO) during index admission (any stage), All-cause mortality by day 30

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 7, 2026