Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3,242
- 试验地点
- 16
- 主要终点
- The proportion of patients experiencing an in-hospital seizure
研究概览
简要总结
The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.
详细描述
Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TxA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TxA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TxA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TxA is used directly on the tissues (topically) for other type of surgeries (joints), TxA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TxA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.
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
The pharmacy will prepare 2 syringes of 50 ml of topical TxA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TxA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.
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
- •≥ 18 years of age
- •Undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (CABG), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy
- •Provide written informed consent
排除标准
- •Allergy to tranexamic acid
- •Undergoing minimally invasive surgery
- •Fulfill any of the following transfusion risk factors (A-D):
- •A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active)
- •History of previous cardiac surgery
- •Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis
- •Pre-operative hemoglobin > 170 g/L or <110 g/L
- •Pre-operative thrombocytopenia (<50,000 platelets per µL)
- •Expected circulatory arrest
- •Pregnancy or breast feeding
- •Previously enrolled in the DEPOSITION trial
- •Refusal of blood products
- •Pericardiectomy
研究组 & 干预措施
Topical Tranexamic Acid/Placebo
Topical Tranexamic Acid 5g to 10g (50 to 100mL) or placebo. The topical will be poured into the pericardial and mediastinal cavities after protamine administration.
干预措施: Tranexamic Acid (Drug)
Intravenous Tranexamic Acid/Placebo
Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
The proportion of patients experiencing an in-hospital seizure
时间窗: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) is superior to the usual intravenous tranexamic acid administration for reducing the risk of in-hospital seizure.
次要结局
- The proportion of patients in-hospital who receive red blood cell transfusions(Start of surgery to hospital discharge or 10 days maximum (whichever occurs first))