Novel coronavirus 2019 (COVID-19) has emerged as a major international public healthconcern. While much of the morbidity and mortality associated with COVID-19 has beenattributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emergingdata suggest that disorders of coagulation, in particular hypercoagulability and venousthromboembolism (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 TangN, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulationtesting results, especially markedly elevated D-dimer and FDP, have been associated witha poor prognosis in COVID-19 infection. We propose the following Electronic Health Record(EHR)-guided 10000-patient, retrospective observational cohort study to assess VTEincidence, risk factors, prevention and management patterns, and thrombotic outcomes inpatients with COVID-19 infection. In order to gain the valuable perspective of otherregional and national centers providing care for large populations of COVID-19, we havestarted a collaborative network with 5 additional sites which will provide us withde-identified data from 1000 patients each. These 5000 patients in addition to the5000-patient cohort we are enrolling within the Mass General Brigham Network willcomprise this study population.
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:
1. Positive COVID-19 PCR AND
2. 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.
Other: No intervention
No intervention
1. Positive COVID-19 PCR AND
2. Inpatient OR outpatient management of COVID-19 infection
Brigham and Women's Hospital
Boston, Massachusetts, United States
Investigator: Gregory Piazza, MD, MS
Contact: 617-732-6984
gpiazza@partners.org
Gregory Piazza, MD, MS
617 732 6984
gpiazza@partners.org
Gregory Piazza, MD, MS, Principal Investigator
BWH