The Dose Effect of Activated Clotting Time and Tranexamic Acid on Bleeding in Adult Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery.
The main questions it aims to answer are:
- Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
- Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?
Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.
详细描述
This study is going to analyze the medical records of patients who underwent cardiac surgery between December 1, 2023, and December 31, 2026.
The investigators will categorize patients into four groups based on anticoagulation indices (ACT 400-600 seconds; ACT > 600 seconds) and tranexamic acid dosages (low dose; high dose) within the range considered safe for CPB.
The primary outcome will be the volume of postoperative bleeding within 24 hours for each group.
The findings of this study will contribute to the existing clinical evidence and provide insights for the monitoring and pharmacological management in 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the research process, any raw data will be kept and encrypted by the principal investigator, and it will not be accessible or interpretable by others.
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
- •adult, cardiac surgery with cardiopulmonary bypass
排除标准
- •emergency procedure
- •immune compromised
- •aortic surgery
- •end-stage renal disease
- •liver disease
- •critical status
- •incomplete clinical data
研究组 & 干预措施
High dose tranexamic acid + high ACT level
high dose tranexamic acid: 50mg/kg ACT level: > 600 sec
干预措施: Tranexamic acid (Drug)
High dose tranexamic acid + low ACT level
high dose tranexamic acid: 50mg/kg ACT level: 400~ 600 sec
干预措施: Tranexamic acid (Drug)
Low dose tranexamic acid + low ACT level
Low dose tranxeamic acid: 20mg/kg ACT level: 400~ 600 sec
干预措施: Tranexamic acid (Drug)
Low dose tranexamic acid + high ACT level
Low dose tranxeamic acid: 20mg/kg ACT level: > 600 sec
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Blood loss
时间窗: 24 hours
monitor the amount of blood loss after procedure
blood transfusion
时间窗: procedure time, an average of 6 hours
the amount of blood transfusion during procedure
次要结局
- 30-day mortality(30 days)