Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Entegrion, Inc.
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Method comparison: Deming regression analysis (PCM and ROTEM NATEM)
Study Overview
Brief 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
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Previous enrollment in study
- •Incarcerated
- •Heparin infusion in prior 24 hours
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Correlation between abnormalities(Parameter differences assessed at time of blood sampling)
- Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)(Parameter differences assessed at time of blood sampling)