Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
This prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure.
200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.
Patients belonging to the control group will receive the same volume of saline infusions.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Patients undergoing open radical prostatectomy
排除标准
- •Age < 18 years
- •Patients with drug eluting stent with a double antiplatelet therapy
- •Atrial fibrillation
- •Thrombophilic diathesis
- •Allergy to tranexamic acid
研究组 & 干预措施
1
Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.
干预措施: Tranexamic Acid (Drug)
2
Patients belonging to the control group will receive the same volume of saline infusions.
干预措施: Placebo (Drug)