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临床试验/NCT06601582
NCT06601582招募中不适用

Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial

Instituto Materno Infantil Prof. Fernando Figueira2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月1日最近更新:
适应症

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

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

发起方
Instituto Materno Infantil Prof. Fernando Figueira
申办方类型
Other
责任方
Principal Investigator
主要研究者

Livia Barboza de Andrade

Director of Education

Instituto Materno Infantil Prof. Fernando Figueira

研究点 (2)

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