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This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QPlus Cartridge can measure hypocoagulable and hypercoagulable conditions resulting from the functional interaction of the enzymatic and cellular components of coagulation and therefore, can be invaluable for longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response to anticoagulants.
This single-center, prospective, observational pilot study will characterize changes in the coagulation status of patients with COVID-19 infection during their hospital stay using the Quantra QPlus System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects admitted to floor | COVID-19 patients admitted to the floor as initial place of hospitalization |
| |
| Subjects admitted or transferred to ICU | COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System | Diagnostic Test | Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantra Clot Time results | Coagulation function assessed by the Quantra | Within 24 hours of admission to the hospital |
| Quantra Clot Time results | Coagulation function assessed by the Quantra | 48 to 72 hours after transfer to ICU |
| Quantra Clot Time results | Coagulation function assessed by the Quantra | 1 to 24 hours prior to discharge from hospital |
| Quantra Clot Stiffness results | Coagulation function assessed by the Quantra | Upon arrival at hospital |
| Quantra Clot Stiffness results | Coagulation function assessed by the Quantra | 48 to 72 hours after transfer to ICU |
| Quantra Clot Stiffness results | Coagulation function assessed by the Quantra | 1 to 24 hours prior to discharge from hospital |
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Inclusion Criteria:
Exclusion Criteria:
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Potential subjects will be adult (>=18 years) patients with a diagnosis of COVID-19 disease admitted to the hospital for treatment of their disease. Subjects will be enrolled at a ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of hospitalization.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center El Paso | El Paso | Texas | 79905 | United States |
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| ID | Term |
|---|---|
| D004211 | Disseminated Intravascular Coagulation |
| D020141 | Hemostatic Disorders |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
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|
| D019851 | Thrombophilia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |