Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Post-operative Blood Loss
研究概览
简要总结
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
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
- •Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)
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)
- •Patients with documented DVT or PE at screening or in past three months.
- •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
end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
干预措施: Tranexamic acid + Standard of Care (Drug)
B
Standard of Care
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Post-operative Blood Loss
时间窗: Post-operation, Day 1, Day 2 up to drain removal
Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. 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))
- Total Blood Loss(Baseline through Day 2 post-surgery)
- Total Blood Loss as Assessed by the Gross' Formula(Baseline through Day 2 post-surgery)
- Percentage of Participants Receiving Transfusions(Up to Day 7 post-surgery)
- Hemoglobin Levels(End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery)
- Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery(Day 7 post-surgery)