COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NET)
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|ClinicalTrials.gov Identifier: NCT04535128|
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment|
|Covid19 Thrombosis Embolism DVT Pulmonary Embolism Myocardial Infarction Stroke||Other: No intervention|
Aim #1: To determine the 30-day and 90-day frequencies of adjudicated, symptomatic arterial and venous thromboembolic events in patients with COVID-19 infection. Symptomatic VTE is defined as symptomatic DVT or PE, confirmed by imaging, within 30 days of randomization. Arterial thromboembolism will be comprised of myocardial infarction, stroke or systemic embolism, acute limb ischemia.
Aim #2: To determine VTE-related risk factors, prevention and management patterns, and 30-day and 90-day all-cause mortality, bleeding, and thrombotic outcomes in patients with COVID-19 infection. 30- and 90-day bleeding outcomes will include ISTH-major and clinically-relevant nonmajor bleeding. Thrombotic outcomes will include symptomatic VTE, myocardial infarction, stroke or systemic embolism, acute limb ischemia, and cardiovascular death.
Aim #3: To determine through multivariate logistic regression modeling, independent risk factors for VTE in patients with COVID-19 infection that could be used to identify those who may benefit from thromboprophylaxis during hospitalization and after discharge.
Study Design: 10000 patient U.S.-based EHR-guided, retrospective observational cohort analysis. Data will abstracted through the EHR. Because this is a computer-generated observational retrospective registry, informed consent will not be practical. Accordingly, we will ask our Institutional Review Board to waive the requirement for informed consent. Participating sites (University of Colorado, Jefferson Health, BIDMC, Anne Arundel Medical Center, and another site to be named) will obtain IRB approval at their own institutions.
Study Population: Patients are eligible if they are ≥18 years of age and meet the following criteria:
- Positive COVID-19 PCR AND
- Inpatient OR outpatient management of COVID-19 infection
Patient Enrollment: We will create a search engine query through the EHR to identify patients with an objective COVID-19 diagnosis who are hospitalized or being treated as outpatients. This will be executed retrospectively for patients already objectively-diagnosed at participating clinical sites.
Primary Outcome: 30-day and 90-day frequency of objectively confirmed, adjudicated arterial thromboembolism or VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE).
Secondary Outcome: 30-day and 90-day frequency of adjudicated all-cause death, bleeding, and thromboembolic outcomes.
Additional Variables of Interest: Additional measured variables will include VTE-related risk factors, prevention and management patterns, and cause of death. We will review the notes and diagnostic testing sections of the Electronic Health Record to complete an electronic case report form for each subject.
Follow-Up: Follow-up will consist of Electronic Health Record review at 30 days and 90 days from study entry.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||90 Days|
|Official Title:||COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NETWORK)|
|Actual Study Start Date :||March 24, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 30, 2021|
Patients with positive COVID-19 PCR
Other: No intervention
- Frequency of arterial or venous thromboembolism over 30 days [ Time Frame: 30 days ]Frequency (%) of arterial or venous thromboembolism
- Frequency of arterial or venous thromboembolism over 90 days [ Time Frame: 90 days ]Frequency (%) of arterial or venous thromboembolism
- Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days [ Time Frame: 30 days ]Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
- Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days [ Time Frame: 90 days ]Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535128
|Contact: Gregory Piazza, MD, MS||617 732 email@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Gregory Piazza, MD, MS 617-732-6984 firstname.lastname@example.org|
|Principal Investigator:||Gregory Piazza, MD, MS||BWH|