NCT03679481撤回4 期
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Transfusion requirements as assessed by number of packed red blood cell units received
研究概览
简要总结
The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.
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, Investigator)
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 admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.
排除标准
- •Preoperative use of any anticoagulant
- •History of deep venous thrombosis or pulmonary embolus
- •Allergy to TXA
- •Hepatic dysfunction (AST/ALT > 60)
- •Renal dysfunction (Cr > 1.5 or GFR < 30)
- •History of cerebrovascular accident in the past 12 months
- •Active coronary artery disease (event in the past 12 months)
- •Presence of drug-eluting stent
- •Color blindness
- •Presence of an additional acute injury that could contribute to blood transfusion requirements
研究组 & 干预措施
Tranexamic acid (TXA)
Experimental
Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
干预措施: Tranexamic acid (TXA) (Drug)
Normal saline
Placebo Comparator
Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
干预措施: Normal saline (Drug)
结局指标
主要结局
Transfusion requirements as assessed by number of packed red blood cell units received
时间窗: from the time of surgery to hospital discharge (about 3-5 days)
次要结局
- Surgical blood loss as assessed by an intraoperative cell salvage machine(at the time of surgery)
- Surgical blood loss as assessed by change in red blood cell volume(baseline, while in PACU (which is about 4-6 hours after surgery))
- Length of hospital stay(from the time of hospital admission to the time of hospital discharge (about 5 days))
- Number of participants with complications(6 weeks after surgery)
研究者
Stephen Warner
Assistant Professor
The University of Texas Health Science Center, Houston
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