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临床试验/CTRI/2024/11/076136
CTRI/2024/11/076136尚未招募3 期

A Randomized Control trial to evaluate the role/efficacy of single dose intravenous Tranexamic acid at the time of induction of anesthesia for post operative seroma formation in para-umbilical hernioplasty at a tertiary care center

Dr Rachit Jain1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Post operative decrease in seroma formation by reducing drain output.

研究概览

简要总结

Tranexamic acid is a synthetic derivative of the amino acid lysine that exerts an anti-fibrinolytic action, used in the prevention and treatment of excessive bleeding both in primary and secondary care, first described in the 1960s; recent years have seen a resurgence of interest in its use in the management of bleeding and particularly in the context of severe trauma.Intravenous administration of tranexamic acid during major surgery has been shown to reduce postoperative bleeding by 34 percent. Intravenous dose of tranexamic acid (10mg /kg body weight) was usually given with induction of anaesthesia in para-umbilical hernioplasty. To the best of our knowledge, no up-to-date studies act on the effect of tranexamic acid on seroma formation and wound infection after paraumbilical hernioplasty.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • UNCOMPLICATED PARA-UMBILICAL HERNIAS AND AGES BETWEEN 18-70 YEARS.

排除标准

  • Complicated/Strangulated Hernias, Hernias Associated with medical diseases affecting coagulation profile ,chronic renal insufficiency or failure , color or vision disorders, history of thrombo-embolic events, pregnant/lactating women.

结局指标

主要结局

Post operative decrease in seroma formation by reducing drain output.

时间窗: Post operative drain output will be measured on day 1, day 3 and day 5.

次要结局

  • IV tranexamic acid can cause adverse drug reaction(on the time of administration)

研究者

发起方
Dr Rachit Jain
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Rachit Jain

KLE Academy of higher education and research

研究点 (1)

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