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.
Study Type
OBSERVATIONAL
Enrollment
120
Test of blood sample by both PCM and ROTEM
Washington University in St. Louis
St Louis, Missouri, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
COMPLETEDThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGMethod 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)
Time frame: Parameter differences assessed at time of blood sampling
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)
Time frame: 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)
Time frame: Parameter differences assessed at time of blood sampling
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