Oral Versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomized Double-Blind Non-Inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
研究概览
简要总结
Tranexamic acid is commonly administered intravenously during cardiac surgery to reduce perioperative bleeding. Oral tranexamic acid may offer a simpler and less costly alternative, but its effectiveness in patients undergoing off-pump coronary artery bypass grafting has not been adequately established.
TRANSCAB is a randomized, double-blind, parallel-group, non-inferiority clinical trial comparing oral and intravenous tranexamic acid in adults undergoing elective off-pump coronary artery bypass grafting. Participants will receive either oral tranexamic acid before surgery with an intravenous placebo at induction, or oral placebo before surgery with intravenous tranexamic acid at induction.
The primary objective is to determine whether oral tranexamic acid is non-inferior to intravenous tranexamic acid for reducing postoperative blood loss. Secondary objectives include comparing transfusion requirements, postoperative hemoglobin levels, reoperation for bleeding, thromboembolic complications, seizures, acute kidney injury, and other postoperative outcomes.
详细描述
Perioperative bleeding remains an important complication of coronary artery bypass surgery and may lead to blood transfusion, reoperation, prolonged hospitalization, and increased postoperative morbidity. Tranexamic acid is an antifibrinolytic drug widely used in cardiac surgery to reduce bleeding and transfusion requirements. It is most commonly administered intravenously, although oral administration may provide adequate systemic exposure while simplifying drug preparation and administration.
TRANSCAB is a monocentric, prospective, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority trial conducted in adult patients undergoing elective off-pump coronary artery bypass grafting.
A total of 160 participants will be randomized in a 1:1 ratio to one of two treatment groups:
- Oral tranexamic acid group: four 500 mg tranexamic acid tablets administered approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
- Intravenous tranexamic acid group: four matching oral placebo tablets administered approximately 2 hours before surgical incision, together with 1 g intravenous tranexamic acid administered at induction or incision according to the study protocol.
Participants, clinicians involved in perioperative management, outcome assessors, and investigators will remain blinded to treatment allocation. Study treatments will be prepared and dispensed according to the randomization list by the hospital pharmacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A double-dummy design is used. Participants receive either oral tranexamic acid and intravenous placebo or oral placebo and intravenous tranexamic acid. Participants, perioperative care providers, investigators, and outcome assessors are unaware of treatment allocation. The randomization list is held by the hospital pharmacy, with emergency unblinding available according to the protocol.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •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.
- •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.
- •Written informed consent obtained before randomization.
- •Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery.
- •Available for in-hospital follow-up and Day 30 assessment.
排除标准
- •Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.
- •Inability to provide informed consent or comply with the required follow-up.
- •Hypersensitivity to tranexamic acid or any excipient of the study products.
- •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.
- •Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
- •Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access.
- •Pregnancy or breastfeeding.
- •Participation in another interventional clinical trial that could interfere with study outcomes or safety.
- •Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid.
- •Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.
- •Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.
研究组 & 干预措施
Oral Tranexamic Acid
Participants receive 2 g of oral tranexamic acid as four 500 mg tablets approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
干预措施: Oral tranexamic acid (Drug)
结局指标
主要结局
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
时间窗: From completion of surgery to 24 hours postoperatively
Total cumulative volume of blood collected from mediastinal and pleural chest drains during the first 24 hours after completion of surgery, expressed in milliliters.
次要结局
- Number of Participants Receiving Red Blood Cell Transfusion(From surgery until hospital discharge, up to 30 days)
- Hemoglobin Concentration at 24 Hours After Surgery (g/dL)(At 24 hours after surgery)
- Number of Participants Requiring Reoperation for Bleeding(During the index hospitalization, up to 30 days)
- Number of Participants With Thromboembolic Events(From study intervention until 30 days after surgery)
- Number of Participants With Postoperative Seizures(During the index hospitalization, up to 30 days)
- Number of Participants With Acute Kidney Injury According to Kidney Disease: Improving Global Outcomes (KDIGO) Criteria(Within 7 days after surgery or until hospital discharge, whichever occurs first)
- Number of Participants With All-Cause Mortality Within 30 Days After Surgery(Within 30 days after surgery)
- Length of Intensive Care Unit Stay (days)(From intensive care unit admission until discharge from the intensive care unit, up to 30 days)
- Length of Hospital Stay (days)(From the date of surgery until hospital discharge, up to 30 days)
研究者
Benjamin JAVILLIER
Principal Investigator
Clinique Saint-Luc