NCT02080494Unknown不适用
Tranexamic Acid in Orthopaedic Trauma Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- hemoglobin value
研究概览
简要总结
Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected.
The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation
- •Expected blood loss is greater than 300 mL
- •Skeletal maturity
排除标准
- •Pregnant or breastfeeding
- •Patients taking oral contraceptives
- •Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)
- •Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)
- •Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)
- •Renal Insufficiency (creatinine greater than 1.5mg/dL)
- •Open fractures
研究组 & 干预措施
Tranexamic Acid
Experimental
15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
hemoglobin value
时间窗: through postoperative day four
次要结局
- hematocrit value(through postoperative day four)
- number of units of allogenic blood transfused(through postoperative day four)
研究者
研究点 (1)
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