Trauma Equivalency Study of the CORA® and TEG® 5000 Systems

NCT ID: NCT02408029

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 325 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-10-31

Brief Summary

This study is being performed to obtain data about the CORA System when used in a trauma clinical setting. The CORA analyzer is a new device that is currently being tested in trauma clinical applications and is not yet cleared for this purpose by the Food and Drug Administration (FDA) for sale in the United States.

Detailed Description

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 5000 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.

The study protocol specifies testing using multiple reagents which are similar for both the CORA and TG 5000 systems. Tests are run in duplicate on blood samples taken from patients undergoing treatment for injuries and trauma. 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.

All blood samples drawn for this study will use venous blood. Only citrated or heparinized whole blood samples are used. All samples are tested twice (run in duplicate). Quality Control procedures are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.

Conditions

Trauma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Trauma Patients Group

Patients undergoing treatment for injuries and trauma.

Observational study - no intervention

Intervention Type: OTHER

Interventions

Observational study - no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age and older
• Complete patient history including age, race, gender and type of trauma should be documented

Exclusion Criteria

• Patients under the age of 18
• Native whole blood will not be used in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coramed Technologies LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles E Wade, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Martin A Schreiber, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Mark Walsh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana School of Medicine, South Bend Notre Dame Campus

Locations

Indiana School of Medicine South Bend Notre Dame Campus

South Bend, Indiana, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

01-229

Identifier Type: -

Identifier Source: org_study_id