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临床试验/NCT07116395
NCT07116395尚未招募4 期

Outcomes of Tranexamic Acid With Anticoagulants in Orthopaedic Trauma Procedures: A Prospective Study

Arbi Nazarian, MD2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2027年1月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
Estimated blood loss (EBL) comparison between those who received TXA vs no TXA

研究概览

简要总结

Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased risk of thrombotic complication. Given the safety and efficacy of this medication in one subspeciality of orthopedics, it is warranted to investigate the use of it in another subspeciality where blood loss is also of concern. It is also of the utmost importance to identify medications that can safely be given to our population to not only improve patient outcomes but also decrease patient costs in the setting of significant disparities. The application of these findings to orthopedic trauma is not something that has been largely studied or appears in the literature. We hope to fill this gap of knowledge to allow for the application of a safe and beneficial medication to a much larger subset of patients than that that is already receiving the medication routinely. The use of TXA in orthopedic patients who are on anticoagulation versus those who are not is also not something that has been previously studied and another knowledge gap that we hope to fill.

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
Single (Participant)

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

  • Patients undergoing operative fixation of long bone fractures; Included conditions include femoral neck fractures, intertrochanteric femur fractures, femoral shaft fractures, distal femur fractures, and tibial shaft fractures that undergo surgical management

排除标准

  • Exclusion criteria for this study will be patients under 18 and prisoners

研究组 & 干预措施

No TXA Administered

No Intervention

Yes TXA Administered

Experimental

干预措施: Tranexamic Acid (TXA) (Drug)

结局指标

主要结局

Estimated blood loss (EBL) comparison between those who received TXA vs no TXA

时间窗: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure

Less estimated blood loss after surgery for patients who were administered TXA

次要结局

  • Hospital Length of Stay for Patients who received TXA vs no TXA(EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure)

研究者

发起方
Arbi Nazarian, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arbi Nazarian, MD

Assistant Clinical Professor

University of California, San Francisco

研究点 (2)

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