TraumaNCT02408029
Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
An observational study of Trauma, run by Coramed Technologies LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- How many people
- 325 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or over undergoing care for trauma.
Who may be able to join
- 18 years of age and older
- Complete patient history including age, race, gender and type of trauma should be documented
Who cannot join
- Patients under the age of 18
- Native whole blood will not be used in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Oregon Health and Science University
Portland, Oregon, 97239
Indiana School of Medicine South Bend Notre Dame Campus
South Bend, Indiana, 46601
About this study
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.
Read the 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
- Being tested
- Observational study - no intervention
- Keywords
- Focus, Testing Performance, CORA Hemostasis System
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study - no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Trauma Patients Group | Patients undergoing treatment for injuries and trauma. Receives: Other: Observational study - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day, measured at time of trauma treatment; no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coramed Technologies LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles E Wade, Ph.D., Principal investigator, The University of Texas Health Science Center, HoustonMartin A Schreiber, M.D., Principal investigator, Oregon Health and Science UniversityMark Walsh, M.D., Principal investigator, Indiana School of Medicine, South Bend Notre Dame Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408029
- Sponsor's protocol ID
- 01-229
- Status last verified
- Jan 2016
- First submitted
- 25 Mar 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
- ClinicalTrials.gov ID
- NCT02408029
- Acronym / sponsor ID
- 01-229
- Conditions
- Trauma
- Keywords
- Focus, Testing Performance, CORA Hemostasis System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Coramed Technologies LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma Patients Group | – | Other: Observational study - no interventionPatients undergoing treatment for injuries and trauma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or over undergoing care for trauma.
Key inclusion criteria (2 listed)
- 18 years of age and older
- Complete patient history including age, race, gender and type of trauma should be documented
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Native whole blood will not be used in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study - no intervention | Other | Trauma Patients Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles E Wade, Ph.D. principal investigator
The University of Texas Health Science Center, Houston
Martin A Schreiber, M.D. principal investigator
Oregon Health and Science University
Mark Walsh, M.D. principal investigator
Indiana School of Medicine, South Bend Notre Dame Campus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Coramed Technologies LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 day, measured at time of trauma treatment; no follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.