Heart Disease Clinical Trial
Official title:
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.
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