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VTE risk prediction scores for Deep Vein Thrombosis

N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test a new way to predict which children in the hospital are at risk for developing blood clots. Using this information, doctors may be able to screen more high-risk patients and reduce the number of children who develop blood clots.

Eligible Conditions
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Pediatrics

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of VTE Events
Secondary outcome measures
Total Number of Bleeding Events
Total Number of High-Risk Patients Started on Anticoagulation
Total Number of Patients Started On Anticoagulation If It Was Recommended
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VTE risk prediction scoresExperimental Treatment1 Intervention
Patients in the intervention arm will have their VTE risk prediction scores presented to the study team daily on weekdays via an automated report, which will list patients in descending order of risk severity for review by the VTE research team each weekday. Starting with the highest risk patients, the VTE research team will review each patient and clinical situation, and then the VTE research team will directly discuss risks/benefits of prophylactic anticoagulation with the admitting team. Patients with a risk score <2.5% will not be reviewed, and the investigators anticipate most of the intervention arm patients will fall into this category (based on our previous data, the investigators anticipate >90% of all patients will score <2.5%). The VTE risk report will be re-calculated based on updated EHR data every day at midnight.
Group II: Standard of careActive Control1 Intervention
Patients randomized to the control arm will continue to receive current standard of care anticoagulation practice, which is at the discretion of the admitting team. In general, nearly no pediatric patients are offered prophylactic anticoagulation unless a previous VTE has been identified. This currently is at the discretion of the provider and no risk scoring is used. VTE risk prediction scores will be calculated and stored for analysis, these will not be visible to the study team in real time.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
865 Previous Clinical Trials
655,726 Total Patients Enrolled
Allison P Wheeler, MDStudy DirectorVanderbilt University Medical Center
Buddy Creech, MDStudy ChairVanderbilt University Medical Center

Media Library

VTE risk prediction scores Clinical Trial Eligibility Overview. Trial Name: NCT04574895 — N/A
Deep Vein Thrombosis Research Study Groups: Standard of care, VTE risk prediction scores
Deep Vein Thrombosis Clinical Trial 2023: VTE risk prediction scores Highlights & Side Effects. Trial Name: NCT04574895 — N/A
VTE risk prediction scores 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574895 — N/A
~3873 spots leftby May 2025
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