Hemostasis MonitoringNCT03679286
Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
An observational study of Hemostasis Monitoring, run by Entegrion, Inc. at 3 sites in United States.
Trial summary
To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis Monitoring
- What is being tested?
- PCM and ROTEM
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2018to 31 Mar 2021
- 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: Male and female patients who have a medical management need that requires measurement of their hemostasis status or are at risk of being hypocoagulable or hypercoagulable
Who may be able to join
- Age 18 years or older
- In opinion of investigator, absence of anything that precludes subject from being good study candidate
- Informed consent
- Order for measurement of hemostasis status of patients who are at risk for being hyper-coagulable or hypo-coagulable due to clinical diagnosis or medical need
Who cannot join
- Previous enrollment in study
- Incarcerated
- Heparin infusion in prior 24 hours
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Completed
Ohio State University
Columbus, Ohio, 43210
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Clinical Research Nurse
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Clinical Research Nurse
About this study
Official title: Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications
Read the detailed description
The primary aim of this study is a performance evaluation of the PCM coagulation monitor in comparison to the ROTEM thromboelastometry system.
To include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as PT/PTT, INR) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.
- Conditions
- Hemostasis Monitoring
- Being tested
- PCM and ROTEM
- Keywords
- Coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCM and ROTEMDevice
Test of blood sample by both PCM and ROTEM
| Study group | Role | What they receive |
|---|---|---|
| All subjects | No intervention Receives: Device: PCM and ROTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method comparison: Deming regression analysis (PCM and ROTEM NATEM)
Deming regression will be used to compare the PCM and the ROTEM NATEM assay (which reports clotting time, speed of clot formation, maximal clot firmness and clot lysis)
Measured: Parameter differences assessed at time of blood sampling
Secondary outcomes (2)
Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)
Deming regression will be used to compare the PCM and the ROTEM INTEM and EXTEM assays (which both report clotting time, speed of clot formation, maximal clot firmness and clot lysis)
Measured: Parameter differences assessed at time of blood sampling
Correlation between abnormalities
Correlation between abnormalities as assessed by conventional coagulation assays (such as fibrinogen concentration, CBC, PT, PTT, INR), vital signs, demographics or trauma (if any)
Measured: Parameter differences assessed at time of blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start20 Aug 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostasis MonitoringStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entegrion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679286
- Sponsor's protocol ID
- PCM-002
- Status last verified
- Apr 2020
- First submitted
- 30 Aug 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
- ClinicalTrials.gov ID
- NCT03679286
- Acronym / sponsor ID
- PCM-002
- Conditions
- Hemostasis Monitoring
- Keywords
- Coagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Entegrion, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 20 Sep 2018 (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.
To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications
Detailed description
The primary aim of this study is a performance evaluation of the PCM coagulation monitor in comparison to the ROTEM thromboelastometry system.
To include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as PT/PTT, INR) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: PCM and ROTEMNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who have a medical management need that requires measurement of their hemostasis status or are at risk of being hypocoagulable or hypercoagulable
Key inclusion criteria (4 listed)
- Age 18 years or older
- In opinion of investigator, absence of anything that precludes subject from being good study candidate
- Informed consent
- Order for measurement of hemostasis status of patients who are at risk for being hyper-coagulable or hypo-coagulable due to clinical diagnosis or medical need
Key exclusion criteria (3 listed)
- Previous enrollment in study
- Incarcerated
- Heparin infusion in prior 24 hours
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 |
|---|---|---|
| PCM and ROTEMTest of blood sample by both PCM and ROTEM | Device | All subjects |
Primary outcome
Method comparison: Deming regression analysis (PCM and ROTEM NATEM)
Time frame: Parameter differences assessed at time of blood sampling
Deming regression will be used to compare the PCM and the ROTEM NATEM assay (which reports clotting time, speed of clot formation, maximal clot firmness and clot lysis)
2 secondary outcomes
Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)
Time frame: Parameter differences assessed at time of blood sampling
Correlation between abnormalities
Time frame: Parameter differences assessed at time of blood sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
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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.
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 Hemostasis Monitoring, run by Entegrion, Inc. 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 4 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 16 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Lindsell, PhD (919.536.1500, chris.lindsell@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method comparison: Deming regression analysis (PCM and ROTEM NATEM) (time frame: Parameter differences assessed at time of blood sampling). 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 16 Apr 2020.