The Use of Tranexamic Acid to Reduce the Need for Transfusion 1 Week Post-operatively for Hemiarthroplasty or Intramedullary Nailing Needed to Correct Acute Hip Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Transfusion reduction rate
研究概览
简要总结
BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative blood loss for various orthopaedic procedures including but not limited to total hip arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in 2013 showed that patients who received TXA showed a significant reduction in post-operative transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar to the total hip or knee replacement in that they can result in significant blood loss that requires a post operative transfusion.
STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative transfusion for acute hip fractures repaired with the following two methods, intramedullary nailing for intertrochanteric fracture and hemiarthroplasty.
METHODS: The model for the study is a prospective randomized control trial. Patients will be placed in one of two arms of the study after passing our inclusion criteria. The arms will be for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those not receiving TXA. The patients in each category will have standard post-operative care and laboratory testing. The investigators will record the patients in either arm of the study, whether it be no TXA or TXA, who require post-operative transfusion within 1 week of the operation.
详细描述
This is a prospective randomized control trial. Patients scheduled for either intramedullary nailing for intertrochanteric fractures or for hemiarthroplasty will be selected for the study population.
The proposed research is needed to bridge the gap between the efficacy of TXA in elective, non-emergency procedures (such as total knee arthoplasty and total hip arthroplasty) and its efficacy in emergent acute hip fracture interventions. This study will use intravenous TXA (1g pre-op and 1g post-op) to study its effect on both the reduction of blood loss during intramedullary nail for intertrochanteric fractures and hemiarthroplasty procedures, and the subsequent reduction in the rate of blood transfusion in this patient population.
Both study and control groups will have standard post-operative care and laboratory testing and will be followed for one year post-operatively to record adverse events.
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
- Double (Participant, Investigator)
盲法说明
Both the participants and the operating surgeons, who are members of the investigative team, will be blinded to which study group the participant is in throughout the study period.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture
排除标准
- •Prothrombotic state
- •Cardiac stent within the past year with corresponding antiplatelet therapy
- •Mechanical heart valves
- •Deep vein thrombosis history
- •Aortic stenosis
- •Currently on Coumadin
- •Malignancy
- •Kidney dialysis
- •Non-English speaking patients
- •Medications contraindicated with tranexamic acid.
研究组 & 干预措施
Hemiarthroplasty - Placebo
Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo
干预措施: Placebo (Other)
Intramedullary nail - Tranexamic Acid
Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid
干预措施: Tranexamic Acid (Drug)
Hemiarthroplasty - Tranexamic Acid
Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid
干预措施: Tranexamic Acid (Drug)
Intramedullary nail - Placebo
Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo
干预措施: Placebo (Other)
结局指标
主要结局
Transfusion reduction rate
时间窗: 1 week
Determine the efficacy of Tranexamic Acid (TXA) in the reduction of allogenic blood transfusion within 1 week following either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.
次要结局
- Tranexamic acid post operative complications(1 year)