Equivalency Study of the TEG and CORA Hemostasis Systems

Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790386
• Other study ID #: Coramed 01-144
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: December 16, 2013
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Coramed Technologies LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Focus is on Testing Performance of CORA Hemostasis System.
• Heart Disease

Locations

Country	Name	City	State
United States	Sinai Center for Thrombosis Research, Sinai Hospital	Baltimore	Maryland
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Medstar Health Research Institute - Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Coramed Technologies LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of differences in TEG and CORA hemostasis parameters per patient		Parameter differences assessed at completion of patient surgery	No
Secondary	Measurement of test subjects' CORA Hemostasis Parameters	Measurement of CORA hemostasis parameters for healthy volunteer subjects is necessary to establish Reference Ranges for product.	Hemostasis parameters measured at time of test for each subject	No