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Coagulation Changes Associated With COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460664
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

Study Description
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Brief Summary:
This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.

Condition or disease Intervention/treatment
COVID Disseminated Intravascular Coagulation Coagulation Disorder Diagnostic Test: Quantra System

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 15, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects admitted to floor
COVID-19 patients admitted to the floor as initial place of hospitalization
 Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: QPlus Cartridge
Subjects admitted or transferred to ICU
COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor
 Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: QPlus Cartridge


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential subjects will be adult (>=18 years) patients with a diagnosis of COVID-19 disease admitted to the hospital for treatment of their disease. Subjects will be enrolled at a ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of hospitalization.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460664


Locations
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United States, Texas
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
HemoSonics LLC
More Information
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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT04460664    
Other Study ID Numbers: HEMCS-035
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by HemoSonics LLC:
Viscoelastic testing
Quantra
COVID-19
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Disseminated Intravascular Coagulation
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Thrombophilia