Equivalency Study of the TEG and CORA Hemostasis Systems

Completed

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

In brief

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.

Key facts

Study ID

NCT01790386

Run by

Coramed Technologies LLC

People needed

465

Starts

2013-01-01

Expected to finish

2013-12-01

Last updated by the study team

2013-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or over (both groups)
• Age, gender, ace and disease state documented (both groups)
• In good health (Reference Ranges group only)

You may not qualify if…

• 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)

Where it is running

• Medstar Health Research Institute - Washington Hospital Center — Washington D.C., District of Columbia, United States
• Sinai Center for Thrombosis Research, Sinai Hospital — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Magee-Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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