Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Total Blood Loss
研究概览
简要总结
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing surgery for fracture shaft of femur
排除标准
- •Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia
- •Patients with known coagulopathy
- •Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%)
- •Patients with documented DVT or PE at screening or in past three months
- •Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
- •Patients with any associated major illness (e.g., severe cardiac or respiratory disease)
- •Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
研究组 & 干预措施
A
Tranexamic Acid plus standard of care
干预措施: Tranexamic Acid plus standard of care (Drug)
B
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.
干预措施: Standard of care (Procedure)
结局指标
主要结局
Total Blood Loss
时间窗: Baseline through Day 7 post-surgery
Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
次要结局
- Intra-operative Blood Loss(Day 1 (End of surgery))
- Post-operative Blood Loss(1, 4, 8 and 24 hours post-surgery)
- Total Blood Loss Assessed by Gross' Formula(Day 7 post-surgery)
- Number of Participants Receiving Transfusions(Up to day 7 post-surgery)
- Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery(Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery)
- Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery(Day 5 post-surgery)