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临床试验/CTRI/2024/05/067553
CTRI/2024/05/067553尚未招募3 期

Comparison of the effect of tranexamic acid bolus dose with bolus followed by infusion on perioperative blood loss in adult patients undergoing brain tumour surgery

Vardhaman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月17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
60
试验地点
1
主要终点
The amount of blood loss during surgery in millilitres

研究概览

简要总结

The antifibrinolytic effect of tranexamic acid is well established and studies support its role in cases of neurosurgery to reduce intraoperative blood loss. However, few studies have attempted to evaluate the efficacy of intravenous bolus as compared to continuous intravenous infusion of tranexamic acid in patients undergoing neurosurgery. Keeping these observation in mind, this study is being undertaken to evaluate the efficacy of intravenous bolus dose of tranexamic acid with intravenous bolus followed by continuous infusion of tranexamic acid in neurosurgery patients undergoing brain tumour surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 to 65 years undergoing brain tumour surgery
  • American Society of Anaesthesiologists (ASA) grade I and II only.

排除标准

  • Patients who have a history of allergic reaction to tranexamic acid
  • Patients having previous documented history of thromboembolic disease
  • Patients who have documented coagulopathies diagnosed before surgery
  • Patients with documented hepatic or renal dysfunction.

结局指标

主要结局

The amount of blood loss during surgery in millilitres

时间窗: At the end of surgery i.e. skin closure has finished

次要结局

  • Blood loss during surgery

研究者

发起方
Vardhaman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Utkarsh Rathi

VMMC and Safdarjung Hospital New Delhi

研究点 (1)

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