Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Rate of blood transfusion
研究概览
简要总结
The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:
- The efficacy in reducing blood transfusion for topical tranexamic acid administration
- The safety of tranexemic acid, topically used
As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.
Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.
详细描述
Perioperative blood loss and transfusion are common in elderly patients undergoing bipolar hemiarthroplasty for femoral neck fractures, and are associated with anemia-related morbidity and transfusion-related risk. Although tranexamic acid (TXA) reduces blood loss and transfusion in elective arthroplasty, topical administration has been proposed to preserve local hemostatic efficacy while limiting systemic exposure in this comorbid population, but the optimal topical route in hip fracture surgery remains uncertain.
This study compared the efficacy and safety of topical soaking (TS) and intra-articular (IA) TXA with placebo in patients undergoing bipolar hemiarthroplasty.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly patients (age > 60 years)
- •Femoral neck fractures from low energy mechanism
- •Household ambulator
- •Undergoing cementless bipolar hemiarthroplasty at KCMH
- •Informed consent
排除标准
- •Allergy to TXA
- •History of VTE
- •History of hip surgery, pathological fracture, hip infection
- •Congenital or acquired coagulopathy
- •Hb < 10 g/dL or Platelet < 140,000
研究组 & 干预措施
Retrograde Intraarticular Injection via Drain Tube
Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure
干预措施: Retrograde Intraarticular Injection via Drain Tube (Drug)
Topical Soaking of Tranexamic Acid
Tranexamic acid will be placed to soak the intramedullary canal of the femur and surgical area after sheath closure for 5 minutes and completely remove by sunction
干预措施: Topical Soaking of Tranexamic Acid (Drug)
Standard procedure (placebo)
Standard wound irrigation
干预措施: Placebo Comparator: Standard procedure (placebo) (Drug)
结局指标
主要结局
Rate of blood transfusion
时间窗: 2 years, or until complete enrollment
Proportion of patients received blood transfusion divided by total number of patient in a group
次要结局
- In-hospital mortality(During admission period)
- Calculated blood loss(2 years, or until complete enrollment)
- Any adverse events(2 years, or until complete enrollment)
- Volume of blood transfusion(2 years, or until complete enrollment)
研究者
Kanyakorn Riewruja
Doctor
King Chulalongkorn Memorial Hospital