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临床试验/NCT03646474
NCT03646474已完成不适用

Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

Assiut University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年8月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
change in blood loss

研究概览

简要总结

The Tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after 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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

tranexamic acid group

Active Comparator

干预措施: tranexamic Acid infusion (Drug)

placebo group

Placebo Comparator

干预措施: saline infusion (Drug)

结局指标

主要结局

change in blood loss

时间窗: 1st 24 hours.

Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Assiut University

研究点 (1)

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