Heart DiseaseNCT01790386
Equivalency Study of the TEG and CORA Hemostasis Systems
An observational study of Heart Disease and Focus is on Testing Performance of CORA Hemostasis System., run by Coramed Technologies LLC at 4 sites in United States.
Trial summary
This study is being performed to obtain data about the CORA system, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Focus is on Testing Performance of CORA Hemostasis System.
- How many people
- 465 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Dec 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: For surgical group, and consented patient 18 years of age or over, going through a heart surgical procedure. For Reference Ranges group, helathy subjects 18 years of age or over, not taking medications, having conditions or undergoing treatments that would affect blood hemostasis.
Who may be able to join
- 18 years of age or over (both groups)
- Age, gender, ace and disease state documented (both groups)
- In good health (Reference Ranges group only)
Who cannot join
- Subjects/patients under the age of 18 (both groups)
- On medications affecting hemostasis (Reference Ranges group)
- Having conditions or undergoing treatments affecting hemostasis (Reference Ranges group)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sinai Center for Thrombosis Research, Sinai Hospital
Baltimore, Maryland, 21215
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15147
Mayo Clinic
Rochester, Minnesota, 55905
Medstar Health Research Institute - Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Equivalency Study of the CORA(R) and TEG(R) 5000 Systems
This study is being performed to obtain data about the CORA system, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA). 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 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.
Read the detailed description
The study protocol specifies testing using multiple reagents which are similar for both the CORA and TEG systems. Tests are run on blood samples taken from patients undergoing cardiovascular surgery and cardiology procedures, at two times throughout the procedure. The tests may be performed at three different pairs of times: Pre-Operation and Post-Protamine, or During Operation (Post-Heparin) and ICU, or Pre-Operation and ICU. Patients are selected at random for determination of which pair of times will be used, as long as the number of patients for each of the three groups is approximately the same. 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.
The study protocol also specifies the testing of blood samples from normal, health volunteer subjects for the purpose of determining CORA System Reference Ranges for all of the reagents used in the study. Reference ranges will be constructed following the guidelines specified in CLSI Standard C28-A3c.
All blood samples drawn for this study will use venous blood. Whole blood is not used for these studies; only citrated or heparinized samples are used. All samples are repeated twice (run in duplicate tests). Quality Controls are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.
- Keywords
- hemostasis, thromboelastography, coagulation, TEG
- Medical subject headings
- Heart Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients Group | Patients undergoing cardiovascular surgery and cardiology procedures | |
| Reference Ranges Group | Healthy volunteer subjects for determination of normal hemostasis parameter results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of differences in TEG and CORA hemostasis parameters per patient
Measured: Parameter differences assessed at completion of patient surgery
Secondary outcomes (1)
Measurement of test subjects' CORA Hemostasis Parameters
Measurement of CORA hemostasis parameters for healthy volunteer subjects is necessary to establish Reference Ranges for product.
Measured: Hemostasis parameters measured at time of test for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coramed Technologies LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790386
- Sponsor's protocol ID
- Coramed 01-144
- Status last verified
- Dec 2013
- First submitted
- 8 Feb 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalency Study of the CORA(R) and TEG(R) 5000 Systems
- ClinicalTrials.gov ID
- NCT01790386
- Acronym / sponsor ID
- Coramed 01-144
- Keywords
- hemostasis, thromboelastography, coagulation, TEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Coramed Technologies LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Feb 2013 (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, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA). 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 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.
Detailed description
The study protocol specifies testing using multiple reagents which are similar for both the CORA and TEG systems. Tests are run on blood samples taken from patients undergoing cardiovascular surgery and cardiology procedures, at two times throughout the procedure. The tests may be performed at three different pairs of times: Pre-Operation and Post-Protamine, or During Operation (Post-Heparin) and ICU, or Pre-Operation and ICU. Patients are selected at random for determination of which pair of times will be used, as long as the number of patients for each of the three groups is approximately the same. 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.
The study protocol also specifies the testing of blood samples from normal, health volunteer subjects for the purpose of determining CORA System Reference Ranges for all of the reagents used in the study. Reference ranges will be constructed following the guidelines specified in CLSI Standard C28-A3c.
All blood samples drawn for this study will use venous blood. Whole blood is not used for these studies; only citrated or heparinized samples are used. All samples are repeated twice (run in duplicate tests). Quality Controls 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
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients Group | – | –Patients undergoing cardiovascular surgery and cardiology procedures |
| Reference Ranges Group | – | –Healthy volunteer subjects for determination of normal hemostasis parameter results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For surgical group, and consented patient 18 years of age or over, going through a heart surgical procedure. For Reference Ranges group, helathy subjects 18 years of age or over, not taking medications, having conditions or undergoing treatments that would affect blood hemostasis.
Key inclusion criteria (3 listed)
- 18 years of age or over (both groups)
- Age, gender, ace and disease state documented (both groups)
- In good health (Reference Ranges group only)
Key exclusion criteria (3 listed)
- Subjects/patients under the age of 18 (both groups)
- On medications affecting hemostasis (Reference Ranges group)
- Having conditions or undergoing treatments affecting hemostasis (Reference Ranges group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of differences in TEG and CORA hemostasis parameters per patient
Time frame: Parameter differences assessed at completion of patient surgery
1 secondary outcome
Measurement of test subjects' CORA Hemostasis Parameters
Time frame: Hemostasis parameters measured at time of test for each subject
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 17 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease and Focus is on Testing Performance of CORA Hemostasis System., run by Coramed Technologies LLC at 4 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 3 inclusion and 3 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Measurement of differences in TEG and CORA hemostasis parameters per patient (time frame: Parameter differences assessed at completion of patient surgery). 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 17 Dec 2013.