Hemostasis Monitoring
Conditions
Keywords
Coagulation
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.
Interventions
DEVICEPCM and ROTEM
Test of blood sample by both PCM and ROTEM
Sponsors
Entegrion, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Method comparison: Deming regression analysis (PCM and ROTEM NATEM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM) | Parameter differences assessed at time of blood sampling | 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) |
| Correlation between abnormalities | Parameter differences assessed at time of blood sampling | Correlation between abnormalities as assessed by conventional coagulation assays (such as fibrinogen concentration, CBC, PT, PTT, INR), vital signs, demographics or trauma (if any) |
Countries
United States
Contacts
Primary ContactChris Lindsell, PhD
Backup ContactEntegrion
Outcome results
None listed