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临床试验/NCT02094066
NCT02094066Unknown4 期

The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
hemorrhage

研究概览

简要总结

The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

详细描述

Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 age
  • total hip arthroplasty surgery
  • regional anesthesia

排除标准

  • allergies to drug
  • liver and kidney failure
  • ischemic heart disease
  • coagulopathy

研究组 & 干预措施

serum physiologic

Sham Comparator

preoperative 100 cc serum physiologic

干预措施: serum physiologic (Drug)

tranexamic acid

Active Comparator

preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes

干预措施: tranexamic acid (Drug)

结局指标

主要结局

hemorrhage

时间窗: intraoperative

the amount of bleeding in aspirator and sponges

次要结局

  • erythrocyte transfusion(intraoperative and postoperative 3 days)

研究者

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

seher orbay yasli

resident

TC Erciyes University

研究点 (1)

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