Outcomes of Fresh Frozen Plasma Usage During Cardiopulmonary Bypass in Congenital Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Transfusion
研究概览
简要总结
When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.
详细描述
This will be a single center, retrospective study. Our cohort will include pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass between January 2019 and January 2023. Patients will be divided into two groups: FFP given at onset of CPB and no FFP given intraoperatively. Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded. Patient clinical, surgical, and bypass characteristics, transfusion, and bleeding outcomes will be collected using REDCAP and via chart review using Connect Care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass
排除标准
- •Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded
结局指标
主要结局
Transfusion
时间窗: 24 hours
Units of blood products transfused
Bleeding
时间窗: 24 hours
Chest tube output
次要结局
- Length of stay(5 days)
- Length of ventilation(5 days)