Coagulation Changes Associated With COVID-19 Infection

Completed

• Conditions: COVID; Coagulation Disorder; Disseminated Intravascular Coagulation
• Interventions: Diagnostic Test: Quantra System

• Registration Number: NCT04460664
• Lead Sponsor: HemoSonics LLC

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-07
• Study Start: 2020-08-14
• Primary Completion: 2021-04-28
• Study Completion: 2022-01-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects admitted to floor	Quantra System	COVID-19 patients admitted to the floor as initial place of hospitalization
Subjects admitted or transferred to ICU	Quantra System	COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor

Primary Outcome Measures

Name	Time	Method
Quantra Clot Stiffness results	1 to 24 hours prior to discharge from hospital	Coagulation function assessed by the Quantra
Quantra Clot Time results	1 to 24 hours prior to discharge from hospital	Coagulation function assessed by the Quantra

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center El Paso; 🇺🇸 El Paso, Texas, United States