Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2019 |
| Start Date: | August 20, 2018 |
| End Date: | March 31, 2020 |
| Contact: | Chris Lindsell, PhD |
| Email: | chris.lindsell@vumc.org |
| Phone: | 919.536.1500 |
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
marketed device in adult patients who require hemostasis monitoring or who are at risk of
bleeding or thrombotic indications
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.
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.
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
We found this trial at
3
sites
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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