NCT04460664

Coagulation Changes Associated With COVID-19 Infection

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID
• Disseminated Intravascular Coagulation
• Coagulation Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantra System	Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Timeline

• Start date: 2020-08-14
• Primary completion: 2021-04-28
• Completion: 2022-01-26
• First posted: 2020-07-07
• Last updated: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study