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临床试验/NCT01727843
NCT01727843终止3 期

Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.

Dr. Jeff Yach1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
15
试验地点
1
主要终点
Blood loss

研究概览

简要总结

Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However, concerns about the prothrombotic side effects of systemic administration of TA has hindered the widespread adoption of this medication in orthopaedic patients due to their high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical application of tranexamic acid has been proposed as a way to mitigate the potential prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following topical application, minimizing its potential systemic thromboembolic side effects. TA has been used topically in total knee arthroplasty, with significant reductions in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture surgery is limited, and there are no studies examining topical use of TA in hip fracture surgery.

详细描述

Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by the research assistant will consist of estimated blood loss during surgery, length of stay in hospital, any wound infections as well as any thromboembolic side effects (blood clots in legs and/or heart) that may occur. The number of units of red blood cells transfused will be recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest postoperative hemoglobin levels up to and including post-op day 8 will also be collected as well as any use of ambulatory aids will be recorded on presentation to hospital, discharge and 6 weeks post operatively.

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
Double (Participant, Investigator)

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • hip fracture patients
  • aged 65 and older.

排除标准

  • bilateral femoral neck fracture patient and/or one that is not suited to a hemiarthroplasty repair.

研究组 & 干预措施

tranexamic acid

Experimental

3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.

干预措施: Tranexamic Acid (Drug)

saline

Placebo Comparator

3000mg/mL saline applied directly to the wound at the end of the surgical procedure

干预措施: placebo (Other)

结局指标

主要结局

Blood loss

时间窗: postop 0-8 days.

次要结局

未报告次要终点

研究者

发起方
Dr. Jeff Yach
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Jeff Yach

PI

Queen's University

研究点 (1)

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