Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- intraoperative bleeding volume
研究概览
简要总结
Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs.
The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.
详细描述
It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified.
Two groups of patients:
- TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
- Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blind investigation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.
排除标准
- •Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.
研究组 & 干预措施
Group TA
receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
干预措施: Tranexamic acid injection (Drug)
Group SSI
Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
干预措施: SSI (Drug)
结局指标
主要结局
intraoperative bleeding volume
时间窗: five hours
The blood volume collected in the suction tanks and the operative drapes intraoperatively
次要结局
- bleeding volume in the thoracic drains postoperatively(one month)
- The number of red globular caps transfused for each group(one month)
研究者
Amani Ben Haj Youssef
Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery
University Tunis El Manar