Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Kaolin-activated Clotting Time
研究概览
简要总结
The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform kaolin-based activated clotting time as routine monitor of heparin therapy in patients undergoing cardiac operations. In addition, the device allows the assessment of the patient's coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has been developed. As part of the routine management using S1, tests are also performed on S2. Results are entered into the cardiac surgery data base of all cardiac surgery patients and analyzed.
详细描述
The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to routinely perform kaolin-based activated clotting time (kACT) as monitor of heparin therapy in patients undergoing cardiac operations on cardiopulmonary bypass.
Apart from kACT, the device allows the assessment of the patient's coagulation status by a glass-bead activated test (gbACT+, depicting also clot rate = CR and platelet function = PF). Recently, a new SONOCLOT analyzer (S2) has been developed. Although the S2 shares the technical fundamentals with the S1, the redesign of the device may result in performance changes of kACT and gbACT.
Routine management in cardiac surgery patients is guided using S1 and addition, tests are run on S2. Data are entered into the the cardiac surgery data base and S1 and S2 performance is compared by Bland-Altman analysis and % error calculation in order to establish new reference values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive cardiac surgery patients
排除标准
- 未提供
研究组 & 干预措施
ACT measurements
ACT measurements by SONOCLOT Analyzer during cardiac surgery
干预措施: Sonoclot Analyzer (Device)
结局指标
主要结局
Kaolin-activated Clotting Time
时间窗: Routine measurements during cardiac surgery
次要结局
- Glass Bead Activated Clotting Time(Routine measurements during cardiac surgery)
研究者
Christoph K Hofer
Prof. Dr. med
Triemli Hospital