Official Title
Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
Brief Summary

This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.

Detailed Description

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.

Enrolling by invitation
Disseminated Intravascular Coagulation
Coagulation Disorder

Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Subjects admitted or transferred to ICU
Subjects admitted to floor
Other Name: QPlus Cartridge

Eligibility Criteria

Inclusion Criteria:

- Subject is ≥ 18 years of age

- Subject has a diagnosis of COVID-19 and has been admitted to the hospital

- Subject has one or more risk factors for a poor outcome with COVID-10 disease: advanced age (>=60 years), morbid obesity, diabetes, COPD, CAD

- Subject, or subject's legally authorized representative is willing and agrees to provide informed consent.

Exclusion Criteria:

- Subject is younger than 18 years of age

- Subject is pregnant

- Subject is incarcerated.

- Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.

- Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.

Eligibility Gender
Eligibility Age
Minimum: 18 Years
United States

Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905

HemoSonics LLC
NCT Number
Viscoelastic testing
MeSH Terms
Hemostatic Disorders
Blood Coagulation Disorders
Disseminated Intravascular Coagulation