Comparison of Methods for Coagulation Analysis Between Rotem Sigma (Instrumentation Laboratory, Bedfort, MA, USA) and Quantra System (Hemosonics, Charlottesville, VA USA) in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Equivalence of results of both devices
研究概览
简要总结
Human Research Project Risk Category A. In this study no additional intervention or treatment are performed. The whole blood samples are taken from a routinely placed arterial catheter. The blood loss caused by the two additional blood samples is estimated with 2x 2.7ml. The Risk for the patients to participate in this study is minimal.
Clinical observational study of a point of care in vitro diagnostic device, the Quantra®system (Quantra), that received the CE Mark in April 2017 and is approved by the Swiss Medic for clinical use. The Quantra estimates the coagulation strength of whole blood by sonorheometry technology applying a series of ultrasound pulses to a whole blood sample and measuring its stiffness by returning echoes.
详细描述
The purpose of this study is to investigate to what extent the results of the Quantra corresponds to those of the ROTEM® Sigma (ROTEM). Additionally, the time required for delivery of final results (turnaround time) of all parameters of the Quantra will be examined. Significant differences in the turnaround time between both devices are of high interest as timing is a crucial factor in the diagnosis-based treatment.
Comparison of the coagulation process measurements in turnaround time and results of the ROTEM INTEM CT, HEPTEM CT, EXTEM A10 FIBTEM A10 with corresponding Quantra parameters such as CT, CTH, CTR, CS, PCS, FCS.
The primary aim of the study is to examine whether the two methods of hemostasis analysis are equivalent and how far they correlate.
Secondary aims are to examine the turnaround time of test results in both devices and to examine whether these results would have led to the same therapeutic decisions in a retrospective review of data.
For both devices following data is documented:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for cardiac surgery needing a cardiopulmonary bypass
- •Age older than18 years
- •Written consent of the participation after clarification about the study
排除标准
- •No consent to participate
- •No German comprehension
- •Known coagulation disorder
结局指标
主要结局
Equivalence of results of both devices
时间窗: 1 Year
Difference of EXTEM A10 and FIBTEM A10 (R) was compared with the Platelet Contribution to Clot Stiffness (Q)
Equivalence of the results of both devices
时间窗: 1 Year
HEPTEM CT (R) was compared with the Heparinase Clot ime (Q)
次要结局
- Turnaround time of the measurements(1 Year)
研究者
Werner Baulig
Prof. Dr. med.
Klinik Hirslanden, Zurich