Equivalency Study of the TEG and CORA Hemostasis Systems

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	11/30/2013
Start Date:	January 2013
End Date:	June 2013
Contact:	Norman E Brunner, MS
Email:	nbrunner@coramedtech.com
Phone:	847-647-8800

Equivalency Study of the CORA(R) and TEG(R) 5000 Systems

This study is being performed to obtain data about the CORA system, a new device that is
currently being tested and is not yet cleared for sale in the United State by the Food and
Drug Administration (FDA). 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
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 TEG systems. Tests are run on blood samples taken from patients undergoing
cardiovascular surgery and cardiology procedures, at two times throughout the procedure.
The tests may be performed at three different pairs of times: Pre-Operation and
Post-Protamine, or During Operation (Post-Heparin) and ICU, or Pre-Operation and ICU.
Patients are selected at random for determination of which pair of times will be used, as
long as the number of patients for each of the three groups is approximately the same.
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.

The study protocol also specifies the testing of blood samples from normal, health volunteer
subjects for the purpose of determining CORA System Reference Ranges for all of the reagents
used in the study. Reference ranges will be constructed following the guidelines specified
in CLSI Standard C28-A3c.

All blood samples drawn for this study will use venous blood. Whole blood is not used for
these studies; only citrated or heparinized samples are used. All samples are repeated
twice (run in duplicate tests). Quality Controls are run on both instruments at a frequency
specified by the manufacturers. Results obtained from this testing are not used to make
treatment decisions.

Inclusion Criteria:

- 18 years of age or over (both groups)

- Age, gender, ace and disease state documented (both groups)

- In good health (Reference Ranges group only)

Exclusion Criteria:

- Subjects/patients under the age of 18 (both groups)

- On medications affecting hemostasis (Reference Ranges group)

- Having conditions or undergoing treatments affecting hemostasis (Reference Ranges
group)

We found this trial at

sites

Medstar Health Research Institute - Washington Hospital Center

Washington, District of Columbia 20010

from

Washington,