Coagulation Changes Associated With COVID-19 Infection

HemoSonics

Status

Completed

Conditions

Coagulation Disorder

COVID

Disseminated Intravascular Coagulation

Treatments

Diagnostic Test: Quantra System

Study type

Observational

Funder types

Industry

Identifiers

NCT04460664

HEMCS-035

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.