NCT00587444已完成3 期
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- measure blood loss
研究概览
简要总结
Study has been completed and is in the data analysis and manuscript writing phase of the project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
排除标准
- •Age less than 18 or greater than 90 years; emergency surgery
- •Circulatory arrest
- •Combined non-cardiac procedures such as carotid endarterectomy
- •Congenital heart repair
- •Off-CPB coronary artery bypass grafting (CABG)
- •Clotting disorder
- •Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
- •Aprotinin use
- •Cooling < 28 degrees C during CPB
- •Dialysis dependent renal failure; and
- •Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
研究组 & 干预措施
1
Other
control standard dose heparin dose
干预措施: Heparin (Drug)
2
Active Comparator
high dose heparin dose
干预措施: HH or high heparin (Drug)
3
Active Comparator
hepcon guided therapy
干预措施: heparin concentration HC (Drug)
结局指标
主要结局
measure blood loss
时间窗: within 48 hours
次要结局
- transfusion requirements(48 hours)
研究者
研究点 (1)
Loading locations...
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