Universal Screening for Brain Vascular Injury

(PRaCTUS BCVI Trial)

SW
CZ
Overseen ByCatherine Zwemer, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Inova Health Care Services
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SW

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

I have had a major injury and was treated at a level 1 or 2 trauma center.
I am 18 years old or older.
Patient undergoing whole body trauma CT scan or at least CT cervical spine and/or CTA chest based on the trauma team's concern for major injuries

Exclusion Criteria

I am younger than 18 years old.
Transferred patients
Prisoners

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

Group I: Selective ScreeningActive Control1 Intervention
Group II: Universal ScreeningActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials
80
Recruited
22,700+

American Association for the Surgery of Trauma

Collaborator

Trials
1
Recruited
380+