Transfusion Requirements in Surgical Oncologic Patient
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Composite end-point of mortality and severe complication
研究概览
简要总结
Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 cancer after major abdominal surgery requiring post-operative ICU admission
- •Adults patients
排除标准
- •Age less than 18 year
- •Hematologic Malignances
- •Intensive care unit permanence lower than 24 hours
- •Renal Chronic Failure in Renal Replacement Therapy
- •Karnofsky Status < 50
- •Previous anemia (hemoglobin lower than 9 g/dL)
- •Previous thrombocytopenia (platelet number lower than 50.000/mm3)
- •Previous known coagulopathy
- •Anticoagulation therapy
- •Those unable to receive blood transfusion
- •Patients who refused participation in the study
结局指标
主要结局
Composite end-point of mortality and severe complication
时间窗: 30 days
• The primary purpose of this study is to compare clinical outcomes after oncologic surgery in patients submitted to different strategies of red blood cell transfusion
次要结局
- Hospital Length of Stay(60 days)
研究者
Juliano P Almeida, MD, Principal Investigator
Principal Investigator
University of Sao Paulo