Coagulation Changes Associated With COVID-19 Infection

NCT ID: NCT04460664

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-14

Study Completion Date

2022-01-26

Brief Summary

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

Detailed Description

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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.

Conditions

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COVID Disseminated Intravascular Coagulation Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects admitted to floor

COVID-19 patients admitted to the floor as initial place of hospitalization

Quantra System

Intervention Type DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Subjects admitted or transferred to ICU

COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor

Quantra System

Intervention Type DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Interventions

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Quantra System

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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QPlus Cartridge

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Texas Tech University Health Sciences Center El Paso

El Paso, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HEMCS-035

Identifier Type: -

Identifier Source: org_study_id

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