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This study is being performed to obtain data about the CORA System when used in a trauma clinical setting. The CORA analyzer is a new device that is currently being tested in trauma clinical applications and is not yet cleared for this purpose by the Food and Drug Administration (FDA) for sale in the United States.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma Patients Group | Patients undergoing treatment for injuries and trauma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study - no intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day, measured at time of trauma treatment; no follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years or over undergoing care for trauma.
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| Name | Affiliation | Role |
|---|---|---|
| Charles E Wade, Ph.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Martin A Schreiber, M.D. | Oregon Health and Science University | Principal Investigator |
| Mark Walsh, M.D. | Indiana School of Medicine, South Bend Notre Dame Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana School of Medicine South Bend Notre Dame Campus | South Bend | Indiana | 46601 | United States | ||
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Plasma
| Oregon Health and Science University |
| Portland |
| Oregon |
| 97239 |
| United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |