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Universal Screening for Blunt Cerebrovascular Injury (PRaCTUS BCVI)

30 oktober 2026 uppdaterad av: Inova Health Care Services

Pragmatic Randomized Clinical Trial of Universal Screening for BCVI

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

5000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Virginia
      • Falls Church, Virginia, Förenta staterna, 22042
        • Inova Health System
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Stefan Leichtle, MD, MBA
        • Underutredare:
          • Stephen Varga, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Age 18 or older
  • Major blunt trauma and presented as a trauma activation or consultation at a level 1 or 2 trauma center
  • 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:

  • Transferred patients
  • Prisoners
  • Age less than 18

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Selective Screening

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.
Procedur: Selective 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.
Aktiv komparator: Universal Screening

Participating institution assigned to perform universal screening all adult major blunt trauma patients with CTA of the neck.
Procedur: Universal Screening

Screening all adult major blunt trauma patients with CTA of the neck.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants with BCVI-related Ischemic Stroke
Tidsram: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition

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.
In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of BCVI-Related Stroke per 1000 Major Blunt Trauma Admissions
Tidsram: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)

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.
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
Tidsram: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)

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.
From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Antithrombotic-related bleeding
Tidsram: During the hospitalization for the traumatic event, up to 14 days

Incidence of antithrombotic-related bleeding events
During the hospitalization for the traumatic event, up to 14 days
BCVI detection rate
Tidsram: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition

Rate of BCVI diagnoses per 1000 patients screened
In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition
CTA utilization
Tidsram: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition

CTAs performed per 1000 major blunt trauma admissions per institution
In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Inova Health Care Services

Samarbetspartners

American Association for the Surgery of Trauma

Utredare

  • Huvudutredare: Stefan W Leichtle, MD, MBA, Inova Health Care Services

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

1 november 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

30 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

30 oktober 2026

Första postat (Faktisk)

5 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • INOVA-2026-299

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

No individual patient data will be shared.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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