NCT03090893撤回早期 1 期
A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Percentage of time within the serum AT level target range of 80-100%
研究概览
简要总结
The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization
- •Serum Antithrombin < 60%.
排除标准
- •Heart transplantation during ongoing hospitalization
- •Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)
- •Weight < 40 kg
- •Allergy to goat products
- •Anticoagulation with a direct thrombin inhibitor
- •Religious exception to blood products
- •Hypothermia (< 34°C)
研究组 & 干预措施
Infusion group
Experimental
Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100
干预措施: ATryn continuous infusion (Drug)
结局指标
主要结局
Percentage of time within the serum AT level target range of 80-100%
时间窗: 72 hour infusion period
Target value of Antithrombin is recorded as %
次要结局
未报告次要终点
研究者
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