An interventional study of Selective Screening and Universal Screening in Cerebrovascular Trauma, sponsored by Inova Health Care Services. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Screening
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.
This study evaluates the feasibility of conducting a clinical trial comparing outcomes for selective screening versus universal screening in adult major blunt trauma patients at level 1 and 2 trauma centers in the United States. The primary outcome is BCVI-related ischemic stroke. The secondary outcome is a composite of BCVI-related stroke or stroke-related death.
The design of this study is a pragmatic stepped-wedge cluster-randomized trial. The choice between SS and US is an institutional policy decision rather than an individual patient decision, the unit of randomization is the Trauma Center (TC). Both strategies are widely used at TCs in the United States and considered standard of care. Genuine clinical equipoise exists. The principal risk of US is additional imaging and treatment; the principal risk of SS is a missed injury and a potentially preventable stroke. Neither strategy has been shown to be superior with respect to patient-centered outcomes.
Discussion of the trial and initial findings are expected to facilitate recruitment for the definitive trial, which is anticipated to enroll at least 20 Level 1 and 2 TCs for three or more years.
Inova Health Care Services is the lead sponsor of 86 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Procedure: Selective Screening
Participating institution assigned to perform universal screening all adult major blunt trauma patients with CTA of the neck.
Procedure: Universal Screening
Screening select 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.
Screening all adult major blunt trauma patients with CTA of the neck.
Number of Participants with BCVI-related Ischemic Stroke
BCVI-related ischemic stroke is defined as any ischemic stroke occurring during the hospital stay in a vascular territory suggestive of cervical arterial injury, or any ischemic stroke occurring during the hospital stay in a patient with confirmed BCVI (or before discharge or patient death). Strokes present on admission imaging will be recorded but analyzed separately and not classified as BCVI-related.
Time frame: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition
Incidence of BCVI-Related Stroke per 1000 Major Blunt Trauma Admissions
Incidence of BCVI-related stroke, measured at the population level as events per 1,000 major blunt trauma admissions and compared between screening conditions. BCVI-related stroke is any in-hospital ischemic stroke in a vascular territory suggestive of cervical arterial injury or in a patient with confirmed BCVI; hemorrhagic strokes and strokes on admission imaging are excluded.
Time frame: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)
Incidence of Stroke-Related Mortality per 1,000 Major Blunt Trauma Admissions
Incidence of stroke-related death, measured at the population level as events per 1,000 major blunt trauma admissions and compared between screening conditions. Stroke-related death is any in-hospital death deemed by the treatment team to result primarily from a BCVI-related stroke.
Time frame: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)
Antithrombotic-related bleeding
Incidence of antithrombotic-related bleeding events
Time frame: During the hospitalization for the traumatic event, up to 14 days
BCVI detection rate
Rate of BCVI diagnoses per 1000 patients screened
Time frame: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition
CTA utilization
CTAs performed per 1000 major blunt trauma admissions per institution
Time frame: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition
Plan to share: No — No individual patient data will be shared.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Cerebrovascular Trauma
Inova Health Care Services