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临床试验/NCT02833025
NCT02833025Unknown不适用

Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2018年12月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

James O'Leary

Staff Anesthesiologist

The Hospital for Sick Children

研究点 (1)

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