Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood transfusion rate
研究概览
简要总结
Randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass
详细描述
To evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass, a randomized clinical trial will be conducted. The study will be conducted at a teaching hospital, which is a reference for major cardiac surgeries and receives patients from the Brazilian Unified Health System (SUS). The patients will be randomly assigned to two groups: with and without the use of the system, and allocation concealment will be performed. Continuous variables will be analyzed through frequency distributions and appropriate descriptive measures (mean or median), while categorical variables will be presented through frequency distributions. For categorical variables, the confidence interval will be calculated, conventionally set at 95%. For continuous variables, the T-test will be used to measure differences, while for categorical variables, the McNemar statistical test will be used. For all analyses, a significance level of 5% will be used, and the data will be analyzed according to the intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •all patients undergoing CABG or Valve surgery singly.
排除标准
- •Emergency cardiac surgery;
- •Previous heart surgery;
- •End-stage chronic kidney disease;
- •Inability to receive a blood transfusion (refusal);
- •Anemia (hemoglobin less than 10g/dl);
- •Thrombocytopenia (platelet count less than 100,000/mm3);
- •Coagulopathy (RNI > 1.5);
结局指标
主要结局
Blood transfusion rate
时间窗: 2 days
Reduction in the volume of packed red blood cells administered intrao peratively
次要结局
- Hospital mortality(30 days)
- Hospital Stay(30 days)
- ICU stay(30 days)
- Mechanical ventilation(30 days)
- Re-operation for bleeding(30 days)
- Need for renal replacement therapy(30 days)
研究者
Livia Barboza de Andrade
Director of Education
Instituto Materno Infantil Prof. Fernando Figueira
