Status:
COMPLETED
A Universal Electronic Health Record-based IMPROVE DD VTE Risk Assessment Model for the Prevention of Thromboembolism in Hospitalized Medically Ill Patients
Lead Sponsor:
Northwell Health
Conditions:
Venous Thromboembolism
Arterial Thromboembolism
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study will be a multicenter clustered randomized trial of patients in hospitals in which a universal "SMART on FHIR" platform-based EHR-embedded IMPROVE DD VTE clinical prediction rules (CPRs) wi...
Detailed Description
Investigators, plan to do a study using a pragmatic, randomized design as part of a Quality Improvement (QI) project as a substudy within the existing NIH R18 proposal of creating a universal "SMART o...
Eligibility Criteria
Inclusion
- • Patients with an acute medical illness and ONE of the following risk factors:
- Age \> 60 years
- Presence of known thrombophilia
- Intensive care unit (ICU)/coronary care unit (CCU) stay
- Lower extremity paralysis
- Cancer
- Immobilization
- Previous VTE history
- D-dimer (\>2X ULN)
Exclusion
- • Patients with the following factors:
- Therapeutic anticoagulation
- History of recent bleeding.
- Active gastroduodenal ulcer
- Thrombocytopenia (admission platelet count\< 75x 109 cells/L )
- Coagulopathy (baseline INR \> 1.5)
- Severe renal insufficiency (baseline)CrCl \< 30ml/min)
- Dual antiplatelet therapy
- Bronchiectasis/pulmonary cavitation
- Active cancer, and recent major surgery within 30 days of their index hospitalization bleeding.
Key Trial Info
Start Date :
December 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2022
Estimated Enrollment :
10699 Patients enrolled
Trial Details
Trial ID
NCT04768036
Start Date
December 21 2020
End Date
January 21 2022
Last Update
August 2 2022
Active Locations (5)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030
2
The Institute for Health Innovations and Outcomes Research
Manhasset, New York, United States, 11030
3
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
4
Lenox Hill Hospital
New York, New York, United States, 10075