Equivalency Study of the TEG and CORA Hemostasis 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Disease Cardiovascular Diseases Embolism and Thrombosis Focus is on Testing Performance of CORA Hemostasis System. Heart Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medstar Health Research Institute - Washington Hospital Center, Washington D.C., District of Columbia, United States

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Measurement of differences in TEG and CORA hemostasis parameters per patient

Time frame: Parameter differences assessed at completion of patient surgery

Secondary outcomes

Measurement of test subjects' CORA Hemostasis Parameters

Time frame: Hemostasis parameters measured at time of test for each subject

Measurement of CORA hemostasis parameters for healthy volunteer subjects is necessary to establish Reference Ranges for product.

Sponsors and collaborators

Lead sponsor

Coramed Technologies LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Feb 13, 2013
Registry last updated: Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed