NCT06565364已完成不适用
Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- prevalence of protamine/heparin antibodies
研究概览
简要总结
The primary aim of this study was to describe the prevalence and time course of the occurrence of protamine/heparin antibodies in patients undergoing cardiac surgery on cardiopulmonary bypass.
The second aim was to identify triggers of immunization.
The third aim of this study was to evaluate a potential clinical impact of protamine/heparin antibodies and their platelet-activating properties leading to thromboembolism and other adverse outcomes.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •cardiac surgery on cardiopulmonary bypass
排除标准
- •cardiac surgery without cardiopulmonary bypass
- •age < 18 years
- •no written consent
结局指标
主要结局
prevalence of protamine/heparin antibodies
时间窗: preoperatively until postoperative day 10
次要结局
- Potential triggers(preoperatively)
- Clinical impact(until postoperative day 10)
研究者
Caroline Holaubek, MD
Medical Doctor, Research Fellow
Medical University of Vienna
研究点 (1)
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