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

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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

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.

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
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Saint Louis, Missouri 63110
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Saint Louis, MO
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