NCT01965730终止早期 1 期
The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- degree of fibrinolysis as measured by thromboelastography
研究概览
简要总结
This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to sign informed consent
- •Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest
排除标准
- •Inability to sign informed consent
- •Baseline hypercoagulable condition as defined in medical record
- •Coronary disease with untreated lesions or recent coronary stent placement
- •Severe renal dysfunction (ESRD) as documented in medical record
研究组 & 干预措施
epsilon-aminocaproic acid (EACA)
Active Comparator
75mg/kg loading dose with infusion 15mg/kg/hr
干预措施: epsilon-aminocaproic acid (EACA) (Drug)
EACA
Experimental
125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery.
干预措施: epsilon-aminocaproic acid (EACA) (Drug)
结局指标
主要结局
degree of fibrinolysis as measured by thromboelastography
时间窗: Length of cardiac surgery
The primary objective of the study will be to determine if a change in EACA dosing for cardiac surgery cases involving circulatory arrest actually leads to a quantifiable change in the degree of fibrinolysis as measured by TEG.
次要结局
未报告次要终点
研究者
研究点 (1)
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