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COMPLETEDNCT04460664

Coagulation Changes Associated With COVID-19 Infection

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

Lead sponsor: HemoSonics LLC•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

HemoSonics LLC

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 13, 2022Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment15

Start dateAug 2020

Last updatedMay 13, 2022

Condition

COVID Disseminated Intravascular Coagulation Coagulation Disorder

Locations shown

Texas Tech University Health Sciences Center El Paso

El Paso, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2022Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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