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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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)

Last updated:

6/24/2013

NCT ID:

NCT01790386