Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters

Conditions
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Hemostasis Monitoring

Intervention / Treatment
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* Device: PCM and ROTEM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>No intervention | Device: PCM and ROTEM<br>* Test of blood sample by both PCM and ROTEM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Parameter differences assessed at time of blood sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Parameter differences assessed at time of blood sampling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coagulation