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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408029
• Other study ID #: 01-229
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: January 26, 2016
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Other:
• Observational study - no intervention

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Oregon Health and Science University	Portland	Oregon
United States	Indiana School of Medicine South Bend Notre Dame Campus	South Bend	Indiana

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	Composite measure: Blood coagulation and hemostasis parameters R (min), C-ACT (min), K (min), Angle (degrees), MA (mm) and LY30 (%) parameters for both TEG 5000 and CORA systems		1 day, measured at time of trauma treatment; no follow-up	No