Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
研究概览
详细说明
The purpose of the study is to validate the CORA System by comparing the results of this test to that of the standard of care device called the TEG 5000 system. Both systems evaluate hemostasis, a highly complex and interactive process involving many protein and cellular elements, especially platelets, occurring in a series of interrelated phases, which results in either normal hemostasis or a tendency toward bleeding or clotting complications.
The study protocol specifies testing using multiple reagents which are similar for both the CORA and TG 5000 systems. Tests are run in duplicate on blood samples taken from patients undergoing treatment for injuries and trauma. Following the protocol defined in CLSI Standard EP09-A2, equivalence between the two systems will be demonstrated if the conclusions from the Standard Section 7, Interpreting Results and Comparing to Internal Performance Criteria, are found to be acceptable.
All blood samples drawn for this study will use venous blood. Only citrated or heparinized whole blood samples are used. All samples are tested twice (run in duplicate). Quality Control procedures are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Indiana
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South Bend、Indiana、美国、46601
- Indiana School of Medicine South Bend Notre Dame Campus
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health and Science University
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Texas
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Houston、Texas、美国、77030
- University of Texas Health Science Center at Houston
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 18 years of age and older
- Complete patient history including age, race, gender and type of trauma should be documented
Exclusion Criteria:
- Patients under the age of 18
- Native whole blood will not be used in this study
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Trauma Patients Group
Patients undergoing treatment for injuries and trauma.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Composite measure: Blood coagulation and hemostasis parameters R (min), C-ACT (min), K (min), Angle (degrees), MA (mm) and LY30 (%) parameters for both TEG 5000 and CORA systems
大体时间：1 day, measured at time of trauma treatment; no follow-up
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1 day, measured at time of trauma treatment; no follow-up
|
合作者和调查者
调查人员
- 首席研究员：Charles E Wade, Ph.D.、The University of Texas Health Science Center, Houston
- 首席研究员：Martin A Schreiber, M.D.、Oregon Health and Science University
- 首席研究员：Mark Walsh, M.D.、Indiana School of Medicine, South Bend Notre Dame Campus
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.