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临床试验/NCT02352662
NCT02352662撤回不适用

Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

Boston Children's Hospital1 个研究点 分布在 1 个国家开始时间: 2015年4月最近更新:
适应症

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

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

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

David Faraoni

Cardiac Anesthesiologist

Boston Children's Hospital

研究点 (1)

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