- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408029
Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Indiana
-
South Bend, Indiana, United States, 46601
- Indiana School of Medicine South Bend Notre Dame Campus
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Trauma Patients Group
Patients undergoing treatment for injuries and trauma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 1 day, measured at time of trauma treatment; no follow-up
|
1 day, measured at time of trauma treatment; no follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles E Wade, Ph.D., The University of Texas Health Science Center, Houston
- Principal Investigator: Martin A Schreiber, M.D., Oregon Health and Science University
- Principal Investigator: Mark Walsh, M.D., Indiana School of Medicine, South Bend Notre Dame Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.Active, not recruitingTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaRecruitingTrauma Injury | Trauma, MultipleKorea, Republic of
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
University Hospital, AngersRecruiting
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Assistance Publique - Hôpitaux de ParisFrancophone Pediatric Resuscitation and Emergency Group (GFRUP)Completed
-
Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedTrauma, Multiple | Trauma Severity Indices | Injuries, Multiple | Norway/Epidemiology | Trauma Centers/Statistics & Numerical Data
-
University Hospital, ToulouseNot yet recruiting
Clinical Trials on Observational study - no intervention
-
Drexel UniversityCompletedOsteoporosisUnited States
-
The Aurum Institute NPCKarolinska Institutet; Ludwig-Maximilians - University of Munich; University... and other collaboratorsUnknownRespiratory Tract Infections | Tuberculosis, PulmonaryMozambique, South Africa, Tanzania, Gambia
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
University Hospital, Basel, SwitzerlandCompletedPostoperative Complications | Intraoperative Complications | Patient Safety | Risk ManagementNew Zealand, Switzerland, United States, Netherlands, Spain, Austria, Turkey, United Kingdom, Australia, Greece, Ireland, Italy
-
Hôpital Necker-Enfants MaladesUnknown
-
Liverpool School of Tropical MedicineLondon School of Hygiene and Tropical Medicine; Wellcome Trust; University of... and other collaboratorsRecruitingKidney Diseases | Chronic Kidney Diseases | Non-communicable Disease | Non-Communicable Chronic DiseasesMalawi
-
Nanfang Hospital of Southern Medical UniversityThe First Affiliated Hospital of Anhui Medical University; Xiangya Hospital... and other collaboratorsRecruiting
-
RenJi HospitalNot yet recruitingEnd Stage Renal Disease on DialysisChina
-
Nanowear Inc.RecruitingElective Surgical ProceduresUnited States
-
Sheffield Teaching Hospitals NHS Foundation TrustNational Institute for Health Research, United Kingdom; Alexion Pharmaceuticals...Completed