Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Postoperative chest tube blood loss
研究概览
简要总结
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.
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 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤5 years
- •Undergoing cardiac surgery with cardiopulmonary bypass
排除标准
- •Non-english speaking parents/care-givers
- •Refusal to consent
- •Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- •Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (<12 hr)
- •Weight <3 kg
结局指标
主要结局
Postoperative chest tube blood loss
时间窗: 24hr
次要结局
- Length of hospital stay(through study completion, an average of less than one month)
- Transfusion of blood products(24hr)
- Length of ICU stay(within 30 days)
- Inotropes(within 30 days)
- All-cause mortality(within 30 days)
- Postoperative chest tube blood loss(12hr)
- Duration of mechanical ventilation(within 30 days)
- Kidney injury(within 30 days)
研究者
James O'Leary
Staff Anesthesiologist
The Hospital for Sick Children
