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临床试验/NCT02587845
NCT02587845Unknown3 期

Use of Tranexamic Acid(TNA) in Preventing Blood Loss During and After Total Hip Arthroplasty

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
150
试验地点
1
主要终点
Bleeding

研究概览

简要总结

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.

详细描述

Treatment of choice for osteoarthritis of the hip, developmental dysplasia of the hip, and osteonecrosis of the femoral head in older patients. In association with the investigators aging society, the number of patients who will need THA may increase significantly in the next few years [1]. However, in THA, considerable blood loss remains a major problem, which can lead to a need for allogeneic blood transfusion. Such 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, transfusion-related acute lung injury, intravascular hemolysis, transfusion-induced coagulopathy, renal failure, admission to intensive care, and even death. Several effective interventions have been developed to reduce blood loss and postoperative transfusion rates, such as preoperative autologous donation, cell salvage, controlled hypotension, regional anesthesia, and the use of erythropoietin and antifibrinolytics. The antifibrinolytics include aprotinin, tranexamic acid (TXA), and ε-aminocaproic acid, which have different mechanisms of action [8]. TXA is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation, and thus interferes with fibrinolysis. Compared with other antifibrinolytic drugs, TXA is cheaper and safer than aprotinin and more potent than the others. Numerous studies have evaluated the use of antifibrinolytics in orthopedic surgery and have shown them to be effective in reducing blood loss. However, the available clinical trials and meta-analyses lack sufficient statistical power to determine the effectiveness of antifibrinolytic agents in total hip arthroplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Unilateral primary THA
  • Diagnosis - not fracture, elective surgery
  • Revision THA

排除标准

  • Known allergy to TNA
  • Acquired or congenital coagulopathy
  • Current anticoagulation therapy
  • Preoperative hepatic or renal dysfunction
  • Severe ischemic heart disease (Serious cardiac or respiratory disease)
  • A history of thromboembolic disease
  • Refusal of blood products
  • Pregnancy or breastfeeding

研究组 & 干预措施

IV group

Active Comparator

Intravenous tranexamic acid injection Group IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.

干预措施: Tranexamic Acid (IV) (Drug)

Topical group

Experimental

Intra-articular tranexamic acid injection Group Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.

干预措施: Tranexamic Acid (Topical) (Drug)

结局指标

主要结局

Bleeding

时间窗: intraoperatively

Surgical bleeding

次要结局

  • Total Transfusion(5days after surgery)

研究者

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

Youn-Soo Park

Professor

Samsung Medical Center

研究点 (1)

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