Outcomes of Tranexamic Acid With Anticoagulants in Orthopaedic Trauma Procedures: A Prospective Study
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
- 否
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
Yes TXA Administered
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
Arbi Nazarian, MD
Assistant Clinical Professor
University of California, San Francisco
