Clinical Trials Directory

Trials / Completed

CompletedNCT04865913

Venous Thrombosis Virtual Surveillance in COVID-19

Status
Completed
Phase
Study type
Observational
Enrollment
510 (actual)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Emerging evidence suggests that COVID-19 induces a highly prothrombotic state particularly among hospitalized patients based on abnormal coagulation parameters and high rates of venous thromboembolism (VTE). Reported rates of VTE among hospitalized ward (3%) and critically ill (17% to 69%) patients with COVID-19 suggest that the risk of VTE is substantially higher than patients with other acute medical illnesses. VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the most common preventable causes of hospital-associated morbidity and mortality, and most events occur after hospital discharge. The incidence of VTE after hospitalization for COVID-19 is not currently known. However, the combination of COVID-induced hypercoagulability, ongoing recovery, reduced mobility, advanced age, and comorbidities likely confers a high risk of VTE in this setting. 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 at 12 sites in Canada and the United States. Additional objectives are to explore risk factors for VTE post-discharge, characterize the use of pharmacological measures for VTE prevention, assess patient awareness of VTE and provide VTE education.

Conditions

Interventions

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

Timeline

Start date
2021-01-13
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2021-04-29
Last updated
2023-03-24

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04865913. Inclusion in this directory is not an endorsement.