Venous Thrombosis Virtual Surveillance in COVID-19

Completed

• Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Covid19

• Registration Number: NCT04865913
• Lead Sponsor: Ottawa Hospital Research Institute

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.

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.

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

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.

Exclusion Criteria

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,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VTE	90 days	incidence of acute symptomatic VTE at 90 days after hospital discharge

Secondary Outcome Measures

Name	Time	Method
Risk for VTE	90 days	risk factors for VTE after hospital discharge (age, sex, D-dimer, duration of hospitalization, dose of prophylactic anticoagulation during hospitalization)

Trial Locations

Locations (1)

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada