Clinical trial NCT04460664: Coagulation Changes Associated With COVID-19 Infection
Official title: Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Disseminated Intravascular Coagulation
Coagulation Disorder
Keywords: Viscoelastic testing
Quantra
COVID-19
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Quantra Clot Time results
timeFrame: Within 24 hours of admission to the hospital
measure: Quantra Clot Time results
timeFrame: 48 to 72 hours after transfer to ICU
measure: Quantra Clot Time results
timeFrame: 1 to 24 hours prior to discharge from hospital
measure: Quantra Clot Stiffness results
timeFrame: Upon arrival at hospital
measure: Quantra Clot Stiffness results
timeFrame: 48 to 72 hours after transfer to ICU
measure: Quantra Clot Stiffness results
timeFrame: 1 to 24 hours prior to discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
Study officials:
References: