Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Evidence of CPB-induced coagulopathy confirmed by coagulation assays
研究概览
简要总结
This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates weighing greater than 2.5 kg
- •Patients equal to or less than 12 months of age
- •Undergoing elective cardiac surgery with cardiopulmonary bypass
排除标准
- •Emergent procedure
- •The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))
结局指标
主要结局
Evidence of CPB-induced coagulopathy confirmed by coagulation assays
时间窗: Over 6 months
次要结局
未报告次要终点
研究者
David Faraoni
Cardiac Anesthesiologist
Boston Children's Hospital
