Venous Thrombosis Virtual Surveillance in COVID-19

Covid19 Clinical Trial

— VVIRTUOSO  

Official title:

Venous Thrombosis Virtual Surveillance in COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865913
• Other study ID #: 20200677-01T
• Status: Completed
• Start date: January 13, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE	incidence of acute symptomatic VTE at 90 days after hospital discharge	90 days
Secondary	Risk for VTE	risk factors for VTE after hospital discharge (age, sex, D-dimer, duration of hospitalization, dose of prophylactic anticoagulation during hospitalization)	90 days