Blood Coagulation TestNCT03074266
Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older
An observational study of Blood Coagulation Test, run by Accriva Diagnostics at 9 sites in United States.
Trial summary
This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS 7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Test
- What is being tested?
- GEM Hemochron 100 ACT
- How many people
- 140 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Jun 2017to Dec 2018
- 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: The population to be studied consists of subjects who require parenteral anticoagulant therapy with UFH in accordance with the approved label indications for heparin administration. • Therapeutic Group (T): Patients pre-heparin Patients undergoing procedure requiring anticoagulation with UFH
Who may be able to join
- Therapeutic Group
- Patients meeting all of the following criteria will be considered for entry into the study:
- Males and females 18 years or older.
- Patients scheduled for elective or urgent procedures requiring anticoagulation with UFH.
- Patients requiring heparin anticoagulant therapy for any approved indication and being managed and monitored with the ACT test.
Who cannot join
- The following criteria define the population of subjects who will not be accepted in the study:
- The subject develops a significant, unexpected, concurrent illness or adverse event before the first whole blood sample is drawn.
- The subject with a hematocrit of less than 20% or greater than 55% since these samples are not recommended for testing due to optical densities outside of the Hemochron instrument levels of detection.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Accriva Study Site
Aurora, Colorado, 80045
Accriva Study Site
Baltimore, Maryland, 21215
Accriva Study Site
Chapel Hill, North Carolina, 27514
Accriva Study Site
Charleston, West Virginia, 25304
Accriva Study Site
Falls Church, Virginia, 22042
Accriva Study Site
Los Angeles, California, 90033
Accriva Study Site
New Brunswick, New Jersey, 08903
Accriva Study Site
Sacramento, California, 95816
Accriva Study Site
Takoma Park, Maryland, 20912
About this study
This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS 7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center, prospective method comparison, with data to be analyzed separately from each site as well as combined for all sites.
Read the detailed description
The study will be performed in the clinical setting by trained professional operators.
Group 1: Whole Blood Coagulation Test 1, GEM Hemochron® 100
Group 2: Whole Blood Coagulation Test 2, Hemochron® Signature Elite® 7000 Whole Blood Microcoagulation System
Ex-vivo whole blood samples destined for discard after all medically directed tests are complete will be used from heparinized patients undergoing standard of care interventional procedures in different clinical settings. These include, but are not limited to, the cardiovascular operating room (CVOR), cardiac catheterization lab, surgical intensive care unit (SICU), the electrophysiology (EP) lab, and in extracorporeal membrane oxygenation (ECMO) applications.
A distribution of ACT values is necessary to evaluate clinical accuracy. The target number of subjects for each site is 100.
Samples will be examined at baseline (pre-heparin administration) and at the end of the procedure. Heparinized samples may be obtained for ACT testing once or multiple times while heparin is administered throughout the duration of the procedure. The frequency and time intervals of ACT testing will be determined by the Standard of Care. No additional blood volume or extra blood draws will occur as the result of this study.
The work flow for the testing process will be consistent across all sites. Expected duration of the study is dependent upon the site logistics but generally is expected to last no more than four to six weeks.
ACT results generated from the GEM Hemochron 100 instrument during this study will be used solely for research purposes and will not be used for anticoagulation management of study subjects. No patient follow up is required.
The study will include two GEM Hemochron 100 instruments, trained operators, and two Signature Elite instruments for each procedure.
Guidance was obtained from Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline (CLSI POCT14-A), CLSI EP09-A3: "Method Procedure Comparison and Bias Estimation Using Patient Samples; Approved guideline Third Edition" and peer reviewed literature.
All study data will be collected on Case Report Forms and all analysis will be performed by Accriva.
- Conditions
- Blood Coagulation Test
- Being tested
- GEM Hemochron 100 ACT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEM Hemochron 100 ACTDiagnostic test
Activated Clotting Time
| Study group | Role | What they receive |
|---|---|---|
| Blood coagulation test 1 | Therapeutic: Waste blood from heparinized patients undergoing interventional procedures (standard of care) in different clinical settings will be used to conduct coagulation tests using GEM Hemochron 100 during the course of the procedure before ("baseline") and after heparin administration.
There is no drug administration or therapeutic intervention in this study. The interventional procedure (described above) is standard of care and all results of blood coagulation testing using GEM Hemochron 100 performed in this study are not used to influence that care. Receives: Diagnostic Test: GEM Hemochron 100 ACT | |
| Blood coagulation test 2 | Therapeutic: Waste blood from heparinized patients undergoing interventional procedures (standard of care) in different clinical settings will be used to conduct duplicate coagulation tests using Signature Elite during the course of the procedure before ("baseline") and after heparin administration.
There is no drug administration or therapeutic intervention conducted in the course of this study. The interventional procedure (described above) is standard of care. The only difference in standard of care is that the blood coagulation test is run in duplicate. Receives: Diagnostic Test: GEM Hemochron 100 ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemochron® MCS 7000 Whole Blood Microcoagulation System ACT measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System
Demonstrate that the Hemochron® MCS 7000 Whole Blood Microcoagulation System Activated Clotting Time (ACT) measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device
Measured: Therapeutic: 1 day; Normal: 1 day (duration of a single venous blood collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start8 Jun 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation TestStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accriva Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Rubinstein, MD, Study director, Accriva Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074266
- Sponsor's protocol ID
- HRZ-CSS-15-0002
- Status last verified
- Jul 2018
- First submitted
- 1 Mar 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older
- ClinicalTrials.gov ID
- NCT03074266
- Acronym / sponsor ID
- HRZ-CSS-15-0002
- Conditions
- Blood Coagulation Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Accriva DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Mar 2017 (actual)
- 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 designed to evaluate and verify the clinical accuracy of the Hemochron® MCS 7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center, prospective method comparison, with data to be analyzed separately from each site as well as combined for all sites.
Detailed description
The study will be performed in the clinical setting by trained professional operators.
Group 1: Whole Blood Coagulation Test 1, GEM Hemochron® 100
Group 2: Whole Blood Coagulation Test 2, Hemochron® Signature Elite® 7000 Whole Blood Microcoagulation System
Ex-vivo whole blood samples destined for discard after all medically directed tests are complete will be used from heparinized patients undergoing standard of care interventional procedures in different clinical settings. These include, but are not limited to, the cardiovascular operating room (CVOR), cardiac catheterization lab, surgical intensive care unit (SICU), the electrophysiology (EP) lab, and in extracorporeal membrane oxygenation (ECMO) applications.
A distribution of ACT values is necessary to evaluate clinical accuracy. The target number of subjects for each site is 100.
Samples will be examined at baseline (pre-heparin administration) and at the end of the procedure. Heparinized samples may be obtained for ACT testing once or multiple times while heparin is administered throughout the duration of the procedure. The frequency and time intervals of ACT testing will be determined by the Standard of Care. No additional blood volume or extra blood draws will occur as the result of this study.
The work flow for the testing process will be consistent across all sites. Expected duration of the study is dependent upon the site logistics but generally is expected to last no more than four to six weeks.
ACT results generated from the GEM Hemochron 100 instrument during this study will be used solely for research purposes and will not be used for anticoagulation management of study subjects. No patient follow up is required.
The study will include two GEM Hemochron 100 instruments, trained operators, and two Signature Elite instruments for each procedure.
Guidance was obtained from Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline (CLSI POCT14-A), CLSI EP09-A3: "Method Procedure Comparison and Bias Estimation Using Patient Samples; Approved guideline Third Edition" and peer reviewed literature.
All study data will be collected on Case Report Forms and all analysis will be performed by Accriva.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood coagulation test 1 | – | Diagnostic Test: GEM Hemochron 100 ACTTherapeutic: Waste blood from heparinized patients undergoing interventional procedures (standard of care) in different clinical settings will be used to conduct coagulation tests using GEM Hemochron 100 during the course of the procedure before ("baseline") and after heparin administration. There is no drug administration or therapeutic intervention in this study. The interventional procedure (described above) is standard of care and all results of blood coagulation testing using GEM Hemochron 100 performed in this study are not used to influence that care. |
| Blood coagulation test 2 | – | Diagnostic Test: GEM Hemochron 100 ACTTherapeutic: Waste blood from heparinized patients undergoing interventional procedures (standard of care) in different clinical settings will be used to conduct duplicate coagulation tests using Signature Elite during the course of the procedure before ("baseline") and after heparin administration. There is no drug administration or therapeutic intervention conducted in the course of this study. The interventional procedure (described above) is standard of care. The only difference in standard of care is that the blood coagulation test is run in duplicate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied consists of subjects who require parenteral anticoagulant therapy with UFH in accordance with the approved label indications for heparin administration. • Therapeutic Group (T): Patients pre-heparin Patients undergoing procedure requiring anticoagulation with UFH
Key inclusion criteria (5 listed)
- Therapeutic Group
- Patients meeting all of the following criteria will be considered for entry into the study:
- Males and females 18 years or older.
- Patients scheduled for elective or urgent procedures requiring anticoagulation with UFH.
- Patients requiring heparin anticoagulant therapy for any approved indication and being managed and monitored with the ACT test.
Key exclusion criteria (3 listed)
- The following criteria define the population of subjects who will not be accepted in the study:
- The subject develops a significant, unexpected, concurrent illness or adverse event before the first whole blood sample is drawn.
- The subject with a hematocrit of less than 20% or greater than 55% since these samples are not recommended for testing due to optical densities outside of the Hemochron instrument levels of detection.
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 |
|---|---|---|
| GEM Hemochron 100 ACTActivated Clotting Time | Diagnostic test | Blood coagulation test 1, Blood coagulation test 2 |
Primary outcome
Hemochron® MCS 7000 Whole Blood Microcoagulation System ACT measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System
Time frame: Therapeutic: 1 day; Normal: 1 day (duration of a single venous blood collection)
Demonstrate that the Hemochron® MCS 7000 Whole Blood Microcoagulation System Activated Clotting Time (ACT) measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Marc Rubinstein, MD study director
Accriva Diagnostics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation Test, run by Accriva Diagnostics at 9 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 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Results are not available in the source record.
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?
Hemochron® MCS 7000 Whole Blood Microcoagulation System ACT measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System (time frame: Therapeutic: 1 day; Normal: 1 day (duration of a single venous blood collection)). 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 26 Jul 2018.