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Completed

NCT Number: NCT04460664

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.

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Key information

Conditions

COVID Blood Coagulation Disorders COVID-19 Cardiovascular Diseases Coagulation Disorder Coronaviridae Infections Coronavirus Infections Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombophilia Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantra System

Diagnostic Test

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

Other names: QPlus Cartridge

Primary outcomes

  1. Quantra Clot Time results

    Time frame: Within 24 hours of admission to the hospital

    Coagulation function assessed by the Quantra

  2. Quantra Clot Time results

    Time frame: 48 to 72 hours after transfer to ICU

    Coagulation function assessed by the Quantra

  3. Quantra Clot Time results

    Time frame: 1 to 24 hours prior to discharge from hospital

    Coagulation function assessed by the Quantra

  4. Quantra Clot Stiffness results

    Time frame: Upon arrival at hospital

    Coagulation function assessed by the Quantra

  5. Quantra Clot Stiffness results

    Time frame: 48 to 72 hours after transfer to ICU

    Coagulation function assessed by the Quantra

  6. Quantra Clot Stiffness results

    Time frame: 1 to 24 hours prior to discharge from hospital

    Coagulation function assessed by the Quantra

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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