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.

Completed
COVID
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.
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
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States

HemoSonics LLC
NCT Number
Keywords
Viscoelastic testing
Quantra
Covid-19
MeSH Terms
COVID-19
Hemostatic Disorders
Blood Coagulation Disorders
Disseminated Intravascular Coagulation