Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- total blood loss from surgery to day
研究概览
简要总结
The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive elderly patients (age >75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture.
排除标准
- •Any contraindication for tranexamic acid
- •Multiple fractures
- •Requirement for anticoagulant therapy that could not be stopped.
- •Ongoing thromboembolic event
- •reduced kidney function
- •malignancy,
- •pathological fracture
- •previous operation on the affected hip
- •Active coronary artery disease (event in the past 12 months).
研究组 & 干预措施
Group 1
intravenous tranexamic acid, 15mg/kg, preoperatively, single dose
干预措施: Tranexamic Acid 15mg/kg , iv, Single Dose (Drug)
Group 2
Intravenous normal saline, 100mg, preoperatively, single dose
干预措施: Normal Saline, 100mg, iv, Singe dose (Drug)
结局指标
主要结局
total blood loss from surgery to day
时间窗: 5 days
number of transfusions of allogeneic RBC from surgery up to day 4
时间窗: 5 days
次要结局
- incidence of vascular events(3 months)
- Incidence of deaths(3 months)
研究者
Vasileios S. Nikolaou
Assistant Professor of Orthopaedics
National and Kapodistrian University of Athens