DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Median Volume of Mediastinal Fluid Collected From Participants
研究概览
简要总结
The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.
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 (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA 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 1 syringe of 50 ml of topical TA (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. TA 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
- •Male or female >= 18 years old
- •Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy
- •Provide written informed consent
排除标准
- •Poor (English) language comprehension
- •Minimally invasive valve surgery
- •Off-pump procedures
- •Emergency operations
- •Known history of increased bleeding disorder
- •Thromboembolic disease
- •Allergy to tranexamic acid
- •Severe renal impairment (eGFR <30 mL/min/1.73m2 )
研究组 & 干预措施
TA Topical
1 syringe of 50ml of topical Tranexamic Acid (5g) or placebo. The topical will be poured into the pericardial mediastinal cavities in 2 equal doses, 25ml when the pt comes off-pump and the other 25ml before sternotomy is closed.
干预措施: Tranexamic Acid (Drug)
TA Intravenous
2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Median Volume of Mediastinal Fluid Collected From Participants
时间窗: Fluid collected in the first 24 hours after the surgical procedure
Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure
次要结局
- Number of Participants With Mortality(Patients will be followed post-operatively until hospital discharge)
- Number of Participants With Re-operation for Bleeding or Tamponade(Patients will be followed post-operatively until hospital discharge)
- Median Number of Hours Participants Spent in ICU(Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).)
- Mean Concentration of TxA in Plasma Collected From Participants(on arrival in ICU within 3 hours)
- Number of Participants With Seizures(Patients will be followed post-operatively until hospital discharge)
- Number of Participants With RBC Transfusion(Intra-operative and post-operative RBC transfusions)