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临床试验/NCT02580227
NCT02580227Unknown4 期

The Effect of Preoperative Tranexamic Acid on Blood Loss and Transfusion Rates in Intertrochanteric and Subtrochanteric Femur Fractures.

Good Samaritan Regional Medical Center, Oregon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
Perioperative Blood Loss

研究概览

简要总结

The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.

详细描述

Tranexamic Acid has a long and proven history of clinical safety and effectiveness in the Orthopaedic literature. Its use in perioperative blood management in total joint arthroplasty is wide spread and is quickly becoming a standard of care. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited. There is a logical expectation that the use of TXA in lower extremity fracture care will provide a similar benefit in minimizing blood loss and reducing transfusion requirements, based on TXA's success in total joint arthroplasty, however this has not yet been validated in the literature. This study will seek to evaluate the effectiveness of TXA in perioperative blood management within a subset of lower extremity fracture, specifically intertrochanteric femur fractures. Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications. Intertrochanteric femur fractures have an increased risk of post-operative blood transfusion when compared to femoral neck fractures. It is presumed that the difference in blood loss between these two fracture types is caused by increased pre-operative bleeding of intertrochanteric fractures secondary to the extracapsular nature of the fracture, as opposed to a tamponade effect that occurs with intracapsular femoral neck fractures. It can therefore be expected that the use of TXA in intertrochanteric femur fractures will decrease perioperative bleeding leading to a decrease in total blood loss and a decrease in transfusion rates.

Limited research has shown that TXA is effective in reducing perioperative blood loss in hip fracture when compared to placebo, but not as effectively as when used in joint arthroplasty. One explanation for this difference is that TXA is circulating at the time of iatrogenic fracture in total joint arthroplasty or given shortly after, whereas intraoperative TXA administration in hip fractures usually doesn't occur until 6-48 hours after the initial injury. Administering TXA at the time of hospital admission in intertrochanteric femur fracture allows the drug time to decrease blood loss resulting from the fracture as well as the subsequent surgical intervention.

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
Triple (Participant, Care Provider, Investigator)

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 sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.
  • Patients who are willing and able to consent to participate in the study
  • >18 years of age

排除标准

  • Patients with an allergy to tranexamic acid.
  • History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),
  • History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)
  • Coronary stents
  • History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).
  • Color blindness
  • Subarachnoid hemorrhage

研究组 & 干预措施

Tranexamic Acid

Active Comparator

Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

干预措施: Tranexamic Acid (Drug)

Placebo

Placebo Comparator

Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

干预措施: Placebo (Other)

结局指标

主要结局

Perioperative Blood Loss

时间窗: Admission to discharge, 3-4 days on average.

Perioperative blood loss measured by serial hemoglobin and hematocrit

Blood Transfusion Rates

时间窗: Admission to discharge, 3-4 days on average.

次要结局

未报告次要终点

研究者

发起方
Good Samaritan Regional Medical Center, Oregon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Yakel

Orthopedic Resident

Good Samaritan Regional Medical Center, Oregon

研究点 (1)

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