2026-526581-24-01招募中4 期
Oral versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomised Non-Inferiority Trial (TRANSCAB Study)
Sante et Prevoyance1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cumulative postoperative chest-tube drainage within 24 hours after surgery (mL).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cumulative postoperative chest-tube drainage within 24 hours after surgery (mL).
Cumulative postoperative chest-tube drainage within 24 hours after surgery (mL).
次要结局
- Intraoperative blood loss (mL)
- Chest-drain output at 12 h (mL)
- Time to chest-drain removal (hours)
- Postoperative haemoglobin at 24 h (g/dL)
- All-cause mortality by day 30
- 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)
- 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)
研究者
Clinical Research Unit
Scientific
Sante et Prevoyance
研究点 (1)
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