Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients.
Alexander T Cohen, Robert A Harrington, Samuel Z Goldhaber...
https://pubmed.ncbi.nlm.nih.gov/27232649/Actively Recruiting
Led by Brigham and Women's Hospital · Updated on 2026-02-25
400
Participants Needed
1
Research Sites
182 weeks
Total Duration
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 hospitals 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
Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
G
Gregory Piazza, MD, MS
C
Claire E Galvin, BS
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Brigham and Women's Hospital
Lead Sponsor
Portola Pharmaceuticals
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Electronic Alert (intervention arm) | No Alert (control arm) | Extended‑Duration Prophylaxis (external standard) |
|---|---|---|---|
| What it is | An on‑screen alert enables clinicians to consider extended‑duration, post‑discharge thromboprophylaxis | Usual care without prompting about extended‑duration prophylaxis | Extended‑duration pharmacologic prophylaxis (eg, betrixaban or low‑molecular‑weight heparin for ~35 days) is used to reduce post‑discharge VTE risk in similar patients |
| Role in trial | Alerts prompt clinicians to review guideline‑based prophylaxis options and order extended prophylaxis when indicated | Clinicians do not receive an automated prompt regarding thromboprophylaxis | Guideline‑recommended extended prophylaxis is initiated based on clinician assessment of VTE risk without alert systems |
| Primary purpose | Increase prescribing of extended‑duration thromboprophylaxis after hospital discharge | Maintain usual prescribing patterns without additional prompts | Provide pharmacologic prophylaxis beyond hospitalization in high‑risk medical patients |
| How it works | The alert appears 48 hours after admission with options to order prophylaxis or view guidelines | No on‑screen notification is provided to the clinician | Extended prophylaxis is prescribed verbally or via standard order entry based on clinician judgment and guideline review |
| Evidence and outcomes | Efficacy under investigation for increasing prophylaxis prescribing; trial outcomes pending | Represents baseline prescribing rates and subsequent outcomes | Extended‑duration prophylaxis reduced VTE without increasing major bleeding in the APEX trial |
| Known risks | Safety depends on subsequent prescribing and drug choice; no direct risk from alert itself | No change to existing safety profile of practice | Extended‑duration betrixaban did not increase major bleeding rates compared with short‑duration enoxaparin in APEX trial |
| Limitations | Success depends on clinician action in response to alert and access to medications; alert systems may be bypassed | Deferred prescribing may delay or miss prophylaxis in high‑risk patients | Extended prophylaxis may not benefit all medically ill patients; bleeding risk and cost must be weighed |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Alexander T Cohen, Robert A Harrington, Samuel Z Goldhaber...
https://pubmed.ncbi.nlm.nih.gov/27232649/Brigham and Women's Hospital
Lead Sponsor
Portola Pharmaceuticals
Collaborating Sponsor