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EHR Alerts for Blood Clot Prevention (eVTE Trial)

N/A
Recruiting
Research Sponsored by Scott C. Woller, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient age ≥ 18 years
The encounter must be inpatient
Must not have
Exclude all cases where the patient is being actively prescribed and intended to be discharged on the following qualifying anticoagulant medications: Apixaban, Dabigatran, Dalteparin, Enoxaparin, Edoxaban, Betrixaban, Fondaparinux, Rivaroxaban, Warfarin
Creatinine clearance <30 milliliters/minute based on last-available eligible serum creatinine value preceding discharge
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from discharge to 7 days after discharge
Awards & highlights

Summary

This trial is testing a new algorithm that uses patient age and blood test results to identify patients who may benefit from a blood thinner to decrease their risk of blood clots. The trial will evaluate the use

Who is the study for?
This trial is for patients recently discharged from the hospital who are at high risk of developing blood clots, such as deep vein thrombosis or pulmonary embolism, but have a low risk of bleeding. Specific eligibility criteria details were not provided.
What is being tested?
The study tests if an EHR alert about prescribing rivaroxaban to reduce blood clot risks affects clinician behavior and patient outcomes. Hospitals will activate this alert in monthly blocks to compare results.
What are the potential side effects?
While specific side effects are not detailed here, common side effects of rivaroxaban include bleeding complications, dizziness, headache, elevated liver enzymes, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My medical care requires staying in the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently prescribed any of the listed anticoagulant medications.
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My kidney function is low, with a creatinine clearance under 30 mL/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from discharge to 7 days after discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and from discharge to 7 days after discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
(implementation)
Primary clinical efficacy outcome (effectiveness)
Primary clinical safety outcome

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: At-risk patients for which an alert is sent during the intervention phaseExperimental Treatment1 Intervention
Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), thereby meeting criteria for alerting during the intervention phase
Group II: At-risk patients during the baseline phaseActive Control1 Intervention
Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), and who meet criteria for alerting, but for whom no alert is sent during the baseline phase

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Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor
82 Previous Clinical Trials
53,183 Total Patients Enrolled
Scott C. Woller, MDLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
~65143 spots leftby Jan 2025
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