Topical Application Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 6-hour postoperative bleeding
研究概览
简要总结
This is a single-center, double-blind, randomized controlled trial (RCT) comparing two groups of application of topical dose of tranexamic acid (TxA) versus placebo in patients undergoing coronary artery bypass graft (CABG), off pump coronary bypass graft cardiac surgery (OPCAB), and adult heart valve surgery. The primary outcomes of this study comprised of two parameters; post operative bleeding and blood product transfusion. The primary outcomes were assessed during the operation, until 48-hour post operative.
详细描述
A single center randomized controlled trial (RCT) was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia as the tertiary cardiovascular referral hospital. The RCT was conducted from October 1 th, 2022 until January 6 th, 2023 (current status: completed). This study aims to determine whether topical tranexamic acid is more effective on the amount of bleeding and the need for postoperative blood product transfusion compared with placebo in patients undergoing cardiac surgery and specifically measure the difference outcome between coronary artery bypass graft (CABG), off pump coronary bypass graft cardiac surgery (OPCAB), and adult heart valve surgery. The control group in this study is given 100 mL of normal saline. The subjects were adults undergoing elective cardiac surgery (CABG, OPCAB, and heart valve surgery). Both the patients and the principal investigators were blinded for the treatment-control allocation. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. The primary outcomes of this study comprised of two parameters; post operative bleeding and blood product transfusion. The primary outcomes were assessed during the operation, until 48-hour post operative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects were not aware of the arms/treatment given as they were under general anesthesia during the application of interventions being studied. Besides, during the informed consent for the elective cardiac surgery, subjects were extensively given explanation of the purpose, methods, benefits and risks of the procedure including the randomized nature of the allocation to either arms of the study.
Principal investigators as well as outcomes assessor were kept unaware of the randomization of interventions as they both were restricted for assessing the patients' medical record and the patient identity were coded in the primary database.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages > 18 years old
- •Patients who are scheduled electively for cardiac surgery in National Heart Center Harapan Kita, Jakarta, Indonesia
- •Patients with heart valve disease indicated for aortic or mitral repair/replace
- •Patients with coronary artery disease indicated for CABG or OPCAB surgery
- •Aortic and/ mitral valve surgery concomitant with tricuspid repair
- •Patients who are agreed to participate in this study
排除标准
- •Not willing to become research subjects
- •Allergy to tranexamic acid
- •Undergoing minimally invasive surgery
- •Undergoing double valve (aorta & mitral) procedure and double procedure (CABG+valve, valve+maze)
- •Emergency surgery
- •History of bleeding disorder or coagulopathy
- •History of thromboembolic or hemorrhagic disease
- •Active Infective endocarditis
- •History of previous cardiac surgery
- •Estimated glomerular filtration rate <30 mL/min or on dialysis
- •Receiving oral therapy with clopidogrel, aspirin, dabigatran, or rivaroxaban in the last five days
- •Receiving chronic warfarin therapy who have not stopped their medication and have an international normalized ratio (INR) >1.5 before surgery
- •Pre-operative thrombocytopenia (<50,000 platelets per µL)
- •Pregnancy or breast feeding
- •Refusal of blood products
- •Pericarditis
研究组 & 干预措施
Tranexamic Acid Topical
The treatment of interest was application of Topical Tranexamic Acid (5 gram in 50 mL warm normal saline). The topical will be poured into the pericardial and mediastinal cavities (after protamine administration), and sternum (before chest closure)
干预措施: Tranexamic Acid 100 MG/ML (Drug)
Placebo
The control group is given 100 mL of warm normal saline. The topical will be poured into the pericardial and mediastinal cavities (after protamine administration), and sternum (before chest closure).
干预措施: normal saline (Drug)
结局指标
主要结局
6-hour postoperative bleeding
时间窗: within 6-hour after the surgery
The study parameter is asses the accumulation of drain production within 6 hours postoperatively after surgical procedure
Initial Postoperative bleeding
时间窗: immediately after the surgery
The study parameter is assessed by postoperative chest tube production immediately after the surgery
24-hour postoperative bleeding
时间窗: within 24-hour after the surgery
The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure
48-hour postoperative bleeding
时间窗: within 48-hour after the surgery
The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure
Postoperative blood product transfusion
时间窗: participants will be followed for the duration of ICU and intermediate ward stay, an expected average of 5-7 days
The amount of red blood cell, fresh frozen plasma, thrombocyte concentrate, and cryoprecipitate transfusions the patient receive postoperatively during their stay in the hospital.
次要结局
未报告次要终点
研究者
Dudy Arman Hanafy, Sp. BTKV (K), MARS
Dr.dr.Dudy Arman Hanafy, Sp.BTKV(K)-D, MARS
Indonesia University