Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.
研究概览
简要总结
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
详细描述
A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.
Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.
The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All OR pharmacists are un-blinded to subject randomization.
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
- •Provision of written informed consent
- •Age > or = to 65 years
- •Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
- •Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation
排除标准
- •Indication for closed reduction or percutaneous screw
- •Allergy to TXA
- •Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
- •Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)
研究组 & 干预措施
Intervention
100 cc normal saline with 1g of tranexamic acid in solution
干预措施: Tranexamic Acid Injectable Solution (Drug)
Placebo
100 cc normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.
时间窗: 3 Months
Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.
次要结局
- Complication Rate(3 Months)
- Hospital Readmission(30 Days)
- Mortality Rate(90 Days)
- Length of Stay(From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.)