Status:
UNKNOWN
The Evaluation of Hemostasis in Hospitalized COVID-19 Patients
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Haemonetics Corporation
Inflammatory Markers Laboratory
Conditions:
COVID-19
Eligibility:
All Genders
3+ years
Brief Summary
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been shown to predispose patients to thrombotic disease...
Detailed Description
The investigators hypothesize that serial evaluation of (a) intrinsic thrombogenicity measured by thromboelastography (b) platelet activation and aggregation, and (c) selected biomarkers will provide ...
Eligibility Criteria
Inclusion
- · Confirmed diagnosis of COVID-19 infection using a positive RT-PCR or a positive IgG antibody test prior to or during hospitalization or,
- · With a negative COVID-19 RT-PCR test but with symptoms of possible COVID-19 infection and:
- elevated D-dimer and/or
- positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs · The subject or legal authorized representative able to read and sign an informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).
Exclusion
- Subjects will be excluded from entry if ANY of the criteria listed below are met:
- Less than 3 years of age
- Subject is pregnant
- Active treatment for cancer
- History of long-term use of immunosuppressive agents
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy
- Patients undergoing hemodialysis or peritoneal dialysis
- Patients on full dose anticoagulant at the time of enrollment
- Any condition unsuitable for the study as determined by investigators
Key Trial Info
Start Date :
June 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04493307
Start Date
June 30 2020
End Date
June 1 2021
Last Update
October 22 2020
Active Locations (1)
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1
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21215