Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- proportion of patients requiring packed Red Blood Cell transfusion
研究概览
简要总结
Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 60 years
- •Hip fracture requiring surgical intervention
- •Signs consent and agrees to participate
排除标准
- •Under the age of 60
- •Does not sign consent or refuses participation
- •Known hypersensitivity to tranexamic acid
- •Multiple acute fractures
- •Creatinine clearance <30
- •History of seizures
- •Active hormone therapy
- •History of coagulation abnormality
- •History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
- •Myocardial infarction (MI) and/or stents within the past year
- •History of intracranial hemorrhage
- •Acquired defective color vision
- •Patients admitted directly to nursing units or surgery without stay in the Emergency Center
- •Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital
研究组 & 干预措施
Control Arm
Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.
干预措施: Saline solution (Drug)
Experimental Arm
Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.
干预措施: Tranexamic Acid (TXA) (Drug)
结局指标
主要结局
proportion of patients requiring packed Red Blood Cell transfusion
时间窗: 72 hours
units, perioperative
次要结局
- intraoperative blood loss(24 hours)
- postoperative anemia(72 hours)
研究者
Gregory M Georgiadis MD
Orthopedic Surgeon
ProMedica Health System