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临床试验/NCT01714336
NCT01714336已完成4 期

Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
138
试验地点
1
主要终点
Number of Participants Who Received a Hospitalization Transfusion

研究概览

简要总结

Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

详细描述

Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

placebo

Placebo Comparator

Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

干预措施: placebo (Drug)

tranexamic acid

Active Comparator

Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

干预措施: tranexamic acid (Drug)

结局指标

主要结局

Number of Participants Who Received a Hospitalization Transfusion

时间窗: 5 days

Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

次要结局

  • Number of Participants With Cerebrovascular Accident (CVA) Diagnosis(Within 6 months of surgery)
  • Number of Participants Who Died(6 months after surgery)
  • Number of Participants With Myocardial Infarction (MI) Diagnosis(Within 6 months of surgery)
  • Mean Number of Units Transfused(5 days)
  • Calculated Blood Loss(5 days)
  • Number of Participants With Venous Thromboembolism (VTE) Diagnosis(Within 6 months of surgery)
  • Number of Participants With Wound Complications(Within 6 months of surgery)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Pagnano

M.D.

Mayo Clinic

研究点 (1)

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