Coagulation Changes Associated With COVID-19 Infection

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460664
• Other study ID #: HEMCS-035
• Status: Completed
• Start date: August 14, 2020
• Est. completion date: January 26, 2022

Study information

• Verified date: May 2022
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 26, 2022
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• COVID
• COVID-19
• Disseminated Intravascular Coagulation
• Hemostatic Disorders

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantra Clot Time results	Coagulation function assessed by the Quantra	Within 24 hours of admission to the hospital
Primary	Quantra Clot Time results	Coagulation function assessed by the Quantra	48 to 72 hours after transfer to ICU
Primary	Quantra Clot Time results	Coagulation function assessed by the Quantra	1 to 24 hours prior to discharge from hospital
Primary	Quantra Clot Stiffness results	Coagulation function assessed by the Quantra	Upon arrival at hospital
Primary	Quantra Clot Stiffness results	Coagulation function assessed by the Quantra	48 to 72 hours after transfer to ICU
Primary	Quantra Clot Stiffness results	Coagulation function assessed by the Quantra	1 to 24 hours prior to discharge from hospital