Clinical trial NCT02408029: Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
Official title: Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Focus
Testing Performance
CORA Hemostasis System
Lead sponsor: Coramed Technologies LLC
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or over undergoing care for trauma.

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 day, measured at time of trauma treatment; no follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: South Bend
country: United States
facility: Indiana School of Medicine South Bend Notre Dame Campus
state: Indiana
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Charles E Wade, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Martin A Schreiber, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana School of Medicine, South Bend Notre Dame Campus
name: Mark Walsh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: