A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Thrombin generation - peak amount
研究概览
简要总结
The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.
详细描述
To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full-term neonates (37-42 weeks gestational age)
- •Apgar score of 7 or more at 5 minutes after delivery
- •Surgical placement of BT shunt or repair of an aortic coarctation
- •Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
排除标准
- •Preterm neonates (less than 37 weeks gestation)
- •Apgar score of less than 7 at 5 minutes after birth
- •Emergent procedure
- •Surgical procedure other than placement of BT shunt or repair of aortic coarctation
- •Neonates with a known coagulation defect or coagulopathy
- •Mother with a known coagulation defect or coagulopathy
- •Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
结局指标
主要结局
Thrombin generation - peak amount
时间窗: 2 years
The thrombin generating capacity of plasma is measured using a fluorogenic substrate. Coagulation is initiated by contact activation and thrombin generation is monitored by a microplate fluorometer set that displays the progression of the fluorescence reaction. The peak amount of thrombin generated is expressed by absorbancy (nM).
次要结局
- Thrombin Generation Curve validation in neonates(2 years)
研究者
Nina Guzzetta, M.D.
Associate professor of Anesthesiology
Emory University