Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients.
Alexander T Cohen, Robert A Harrington, Samuel Z Goldhaber...
https://pubmed.ncbi.nlm.nih.gov/27232649Actively Recruiting
Phase Not Applicable
Age: 40Years +
All Genders
ID03728166
Randomized Controlled Trial of Computerized Decision Support for Prevention of Venous Thromboembolism in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
Led by Brigham and Women's Hospital · Updated on 2026-02-25
400
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
P
Portola Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying hospitalized medical patients who face a higher risk of venous thromboembolism (VTE) during and after their hospital stay. This trial evaluates whether an electronic alert system integrated into the hospital's electronic health record (EPIC Best Practice Advisory) can increase the prescription of extended-duration blood clot prevention medication after discharge in high-risk patients. The study also aims to estimate the effect of this alert system on reducing symptomatic VTE events. The trial involves a single-center randomized controlled design with 400 patients aged 40 years or older hospitalized for acute medical illnesses such as heart failure, respiratory failure, infectious disease, rheumatic disease, or ischemic stroke. Patients must have reduced mobility and at least one additional VTE risk factor like age 60 or older, prior VTE, or a history of cancer, and they should not be prescribed clot prevention medication at discharge. Participants are randomly assigned to either receive electronic alerts that prompt clinicians to consider extended-duration thromboprophylaxis with medications like betrixaban or low-molecular weight heparin for 35 days, or to a group with no alert. During the study, researchers will monitor prescription rates of extended-duration thromboprophylaxis using the electronic health record. They will also review records for symptomatic VTE events, major bleeding, death, and rehospitalization within 90 days after randomization. Follow-up is done through electronic health record review without additional visits. The study will provide information on the feasibility and impact of using alert-based decision support for VTE prevention across the care continuum.
CONDITIONS
Brief Title
Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 40 years of age or older
- Hospitalized for acute medical illness such as heart failure, respiratory failure, infectious disease, rheumatic disease, or ischemic stroke
- Have reduced mobility during hospitalization
- Not prescribed thromboprophylaxis at hospital discharge
- Have at least one additional risk factor for VTE: age 60 or older, prior venous thromboembolism, or history of cancer
You will not qualify if you...
- Currently prescribed thromboprophylaxis at hospital discharge
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Outpatient Treatment
Duration - Approximately 35 days starting 48 hours after hospital admission
Participants receive an on-screen electronic alert notifying their healthcare provider about the increased risk for blood clots (VTE) after discharge and the option for extended-duration post-discharge thromboprophylaxis for 35 days.
1 visit during hospitalization for alert delivery; medication prescribed for 35 days post-discharge
Follow-up
Duration - 90 days from randomization
Participants are monitored through review of their electronic health records for up to 90 days after randomization to assess prescription of thromboprophylaxis, occurrence of symptomatic VTE, major bleeding, rehospitalization, and mortality.
No in-person visits; follow-up via electronic health record review
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
G
Gregory Piazza, MD, MS
C
Claire E Galvin, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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