Universal Screening for Brain Vascular Injury
(PRaCTUS BCVI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test whether screening all major blunt trauma patients for blood vessel injuries in the neck and head using CT scans (universal screening) leads to fewer strokes and stroke-related deaths compared to screening only selected patients who meet specific risk criteria (selective screening).
This is a pilot feasibility study. The main questions this study aims to answer are:
Can trauma centers that currently use selective screening successfully switch to universal screening? Are the definitions used to identify and measure outcomes clear and applied consistent across all participating hospitals? Do stroke complications occur frequently enough to support a larger, future clinical trial? Can participating trauma centers reliably track and report the number of CT scans performed for this purpose?
Participating trauma centers in the study will: Continue using their existing selective screening approach at the start of the study Switch to universal CT screening of all major blunt trauma patients at an assigned point during the 12-month study period Submit de-identified patient data to the coordinating center using a secure electronic database Researchers will use the result of this initial feasibility study to determine whether a larger clinical trial comparing the two screening strategies is feasible.
Who Is on the Research Team?
Stefan W Leichtle, MD, MBA
Principal Investigator
Inova Health Care Services
Are You a Good Fit for This Trial?
This trial is for patients who have experienced major blunt trauma, such as from car accidents or falls. There are no specific inclusion or exclusion criteria listed, so it appears open to all major blunt trauma patients treated at participating trauma centers.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of checking for blood vessel injuries in the neck and head after serious injury: screening everyone with a CT scan (universal) versus only those at higher risk (selective). Hospitals will switch between these methods during the study.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participating institution assigned to perform select screening for adult major blunt trauma patients with CTA of the neck based on Denver, Expanded Denver, Memphis, or ACS Best Practices criteria. Participating centers will continue with the screening method currently in place prior so study participation.
Participating institution assigned to perform universal screening all adult major blunt trauma patients with CTA of the neck.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inova Health Care Services
Lead Sponsor
American Association for the Surgery of Trauma
Collaborator
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