Stroke Clinical Trial
— CORONA-VTE NETOfficial title:
COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NET)
Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 1. Positive COVID-19 PCR AND 2. Inpatient OR outpatient management of COVID-19 infection |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Anne Arundel Medical Center, Beth Israel Deaconess Medical Center, Bristol-Myers Squibb, Jefferson Medical College of Thomas Jefferson University, University of Colorado, Denver, University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of arterial or venous thromboembolism over 30 days | Frequency (%) of arterial or venous thromboembolism | 30 days | |
Primary | Frequency of arterial or venous thromboembolism over 90 days | Frequency (%) of arterial or venous thromboembolism | 90 days | |
Secondary | Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days | Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes | 30 days | |
Secondary | Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days | Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes | 90 days |
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