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NCT04535128 · ClinicalTrials.gov registry record
COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications
A clinical trial, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 11,000
- Enrollment target
NCT04535128: Completed study, sponsored by Brigham and Women's Hospital.
NCT04535128 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 11,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04535128 has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 11,000 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Frequency (%) of arterial or venous thromboembolism
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,000 participants |
| Start Date | 2020-03-24 |
| Est. Completion | 2025-08-31 |
What the finished NCT04535128 record still lists
NCT04535128 is an observational study that tracks outcomes without assigning an intervention. Its 11,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT04535128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04535128 about?
NCT04535128 is a clinical study titled "COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications". 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...
What is the current status of trial NCT04535128?
This trial is currently completed. The enrollment target is 11,000 participants. The study started on 2020-03-24. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT04535128?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT04535128?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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