Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCM and ROTEM | Device | Test of blood sample by both PCM and ROTEM |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Male and female patients who have a medical management need that requires measurement of their hemostasis status or are at risk of being hypocoagulable or hypercoagulable
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Lindsell, PhD | Contact | 919.536.1500 | chris.lindsell@vumc.org | |
| Entegrion | Contact | 919.536.1500 | shammonds@entegrion.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
Not provided
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Ohio State University | Completed | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|