Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- To compare mortality between groups 28 day after ICU admission
研究概览
简要总结
Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due 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 patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.
详细描述
Blood transfusion is commonly performed in critically ill patients, particularly in oncologic patients. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in oncologic patients regarding red blood cell transfusions requirements. There are observational and experimental studies suggesting worse outcomes including higher rates of infection and other clinical complications, maybe higher cancer recurrence, in patients submitted to red blood transfusion. Hemoglobin levels around 9 g/dL are usually recommended although not based in evidence . The investigators purpose is to prospectively evaluate two strategies of transfusion in 400 patients with cancer admitted to intensive care unit for severe clinical condition: a liberal strategy - patients receive blood transfusion when hemoglobin is lower than 9 g/dL since the admission to ICU until ICU discharge; a restrictive strategy - patients receive blood transfusion only when hemoglobin is lower than 7 g/dL.
Clinical outcomes, costs and quality of life will be compared.
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
- 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
- •Adults patients with cancer admitted to ICU due to severe clinical condition AND
- •Septic shock diagnosis AND
- •Solid neoplasm AND
- •Written informed consent
排除标准
- •Age less than 18 years OR
- •Leukemia or myelodysplastic syndrome OR
- •Hematologic neoplasm OR
- •Palliative treatment OR
- •Renal Chronic Failure in Renal Replacement Therapy OR
- •Karnofsky Status < 50 OR
- •Previous thrombocytopenia (platelet number lower than 50.000/mm3) OR
- •Previous known coagulopathy OR
- •Life-threatening bleeding OR
- •Documented wish against transfusion OR
- •Patients who refused participation in the study
结局指标
主要结局
To compare mortality between groups 28 day after ICU admission
时间窗: 28 days after ICU admission
次要结局
- To compare length of stay in ICU between groups(90 days)
- To compare length of stay in hospital between groups(90 days)
- To compare days free of organ dysfunction between groups(28 days)
- Adverse effects of transfusion(Followed up until ICU discharge; an expected average of one week)
- Mortality(60 day)
- All cause 90 day mortality All cause 90 day mortality Mortality(90 day)
研究者
Fabricio Sanchez Bergamin
Principal Investigator
Instituto do Cancer do Estado de São Paulo