Venous Thrombosis Virtual Surveillance in COVID-19

NCT04865913 | Completed

• 1 other identifier: 20200677-01T
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of the VVIRTUOSO study is to determine the incidence of VTE including symptomatic DVT and PE after hospital discharge in patients with COVID-19 by implementing a pragmatic patient-centred prospective virtual VTE monitoring program in Canada and the United States.

Conditions

Covid19; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• VTE

  incidence of acute symptomatic VTE at 90 days after hospital discharge

  90 days

Secondary Outcomes (1)

• Risk for VTE

  90 days

Interventions

Observational OTHER

A brief 15 min phone call 1 week, 30 and 90 days post discharge.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were admitted to hospital with COVID-19 or who contracted COVID-19 while in hospital and discharged to anywhere but an acute care hospital.

You may qualify if:

• i) adults 18 years of age or older (or their delegate) ii) admitted to hospital with COVID-19 (laboratory confirmed) or diagnosed with COVID-19 (laboratory confirmed) during hospitalization iii) discharged from acute care hospital within prior 7 days.

You may not qualify if:

• i) unconfirmed diagnosis of COVID-19, ii) no access to a telephone, computer or tablet for virtual assessment, iii) treated with therapeutic doses of anticoagulation after hospital discharge (e.g. atrial fibrillation, mechanical heart valve, previous VTE), iv) patient (or their delegate) is unable or unwilling to provide informed consent,

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

COVID-19; Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Embolism

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: January 13, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CA (1)