跳至主要内容
临床试验/CTRI/2024/03/064938
CTRI/2024/03/064938招募中不适用

Effect of tranexamic acid on intraoperative blood loss in patients undergoing debridement for necrotizing soft tissue infections: A randomized controlled trial.

Nivetha Baskaran1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年4月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
To compare the intraoperative blood loss/ square centimeter of the debrided area in patients undergoing debridement for necrotizing soft tissue infection, with and without tranexamic acid.

研究概览

简要总结

New strategies focused on reducing blood loss are emerging and encouraging. Of these, bipolar diathermy, harmonic scalpel, local vasoconstrictors, induced hypotension, tourniquet application, and antifibrinolytic agents are the most widely used techniques. Tranexamic acid is a synthetic antifibrinolytic agent 7 -10 times more potent than Epsilon-aminocaproic acid. It competitively blocks the lysine-binding site of plasminogen, plasmin, and tissue plasminogen activator, preventing their association with fibrin. Plasminogen conversion to plasmin is thus retarded, and the proteolytic action of plasmin on fibrin monomers and fibrinogen is debarred

We expect tranexamic acid to reduce intraoperative blood loss, the requirement for blood transfusion, and the hospital stay in patients undergoing debridement for necrotizing soft tissue infections.

After registering the trial in CTRI, patients satisfying the inclusion and exclusion criteria will be recruited into the trial. In the intervention group, patients with necrotizing soft tissue infection will receive 1 g of tranexamic acid and patients in the control group will receive 10 ml of normal saline intravenously over 20 mins before beginning the surgery. Debridement will be performed as per the standard of care and intraoperative parameters like blood loss, requirement of blood transfusions, intravenous fluids will be compared between the two groups. Postoperative care will be the same for both the groups and complications like Deep vein thrombosis, Myocardial infarction, Transient ischemic attack. Pulmonary thromboembolism will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patients aged 18 to 65 years undergoing debridement for necrotizing soft tissue infection.

排除标准

  • Patients on anti-platelets.
  • Patients on anti-coagulants.
  • Pregnancy Patients with a history of MI, TIA, CVA, DVT, and PTE.
  • Patients denying consent.
  • Patients hypersensitive to tranexamic acid or its constituent preservative.

结局指标

主要结局

To compare the intraoperative blood loss/ square centimeter of the debrided area in patients undergoing debridement for necrotizing soft tissue infection, with and without tranexamic acid.

时间窗: Intraoperative.

次要结局

  • To compare the intraoperative fluid administration.(To compare the transfusion values (intraoperative and postoperative).)

研究者

发起方
Nivetha Baskaran
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nivetha Baskaran

Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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