The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total postoperative units of red blood cell transfusion
研究概览
简要总结
Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.
详细描述
Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation.
Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.
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
- 是
入选标准
- •Femoral neck, intertrochanteric, subtrochanteric femur fracture
- •Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon
排除标准
- •Concomitant fracture
- •Preoperative anemia needing blood transfusion before surgery
- •Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
- •Allergy for tranexamic acid
- •History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
- •Myocardial infarction in the previous 12 months
- •Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant
- •History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)
研究组 & 干预措施
Early TXA
Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.
干预措施: Tranexamic acid (Drug)
Control
Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Total postoperative units of red blood cell transfusion
时间窗: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.
Change in calculated and recorded hemoglobin
时间窗: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.
次要结局
- Readmission(Within 30 days postoperative)
- VTE(Postoperative for 30 days)
- Infection(Postoperative for 30 days)
- Other complications(Postoperative for 30 days)
研究者
Michael Allen
Principal Investigator
Community Memorial Health System