Equivalency Study of the TEG and CORA Hemostasis Systems

Coramed Technologies

Status: Completed

Conditions: Heart Disease; Focus is on Testing Performance of CORA Hemostasis System.

Study type: Observational

Funder types: Industry

Identifiers

NCT01790386

Coramed 01-144

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 465 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

465 participants in 2 patient groups

Surgical Patients Group

Description:

Patients undergoing cardiovascular surgery and cardiology procedures

Reference Ranges Group

Description:

Healthy volunteer subjects for determination of normal hemostasis parameter results