Universal Screening for Blunt Cerebrovascular Injury (PRaCTUS BCVI)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Stefan W Leichtle, MD, MBA
- Numero di telefono: (703) 776-2274
- Email: stefan.leichtle@inova.org
Backup dei contatti dello studio
- Nome: Catherine Zwemer, MD
- Numero di telefono: (703) 776-2274
- Email: cathzwemer@gmail.com
Luoghi di studio
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Virginia
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Falls Church, Virginia, Stati Uniti, 22042
- Inova Health System
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Contatto:
- Stefan W Leichtle, MD, MBA
- Numero di telefono: 703-776-2274
- Email: stefan.leichtle@inova.org
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Contatto:
- Catherine Zwemer, MD
- Numero di telefono: (703) 776-2274
- Email: Catherine.Zwemer@inova.org
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Investigatore principale:
- Stefan Leichtle, MD, MBA
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Sub-investigatore:
- Stephen Varga, MD
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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. |
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. |
|
Comparatore attivo: Universal Screening
Participating institution assigned to perform universal screening all adult major blunt trauma patients with CTA of the neck. |
Screening all adult major blunt trauma patients with CTA of the neck. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants with BCVI-related Ischemic Stroke
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of BCVI-Related Stroke per 1000 Major Blunt Trauma Admissions
Lasso di tempo: 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)
|
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Incidence of Stroke-Related Mortality per 1,000 Major Blunt Trauma Admissions
Lasso di tempo: 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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Antithrombotic-related bleeding
Lasso di tempo: 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
Lasso di tempo: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition
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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
|
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CTA utilization
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Stefan W Leichtle, MD, MBA, Inova Health Care Services
Pubblicazioni e link utili
Pubblicazioni generali
- Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20.
- Shahan CP, Magnotti LJ, McBeth PB, Weinberg JA, Croce MA, Fabian TC. Early antithrombotic therapy is safe and effective in patients with blunt cerebrovascular injury and solid organ injury or traumatic brain injury. J Trauma Acute Care Surg. 2016 Jul;81(1):173-7. doi: 10.1097/TA.0000000000001058.
- Kelley W, Zreik K, Gergen A, Williams J, Jacobson LE, Nahmias J, Tatar A, Murry J, Grigorian A, Ong A, Stein DM, Scalea TM, Lauerman MH. Early Pharmacologic Therapy in Patients With Blunt Cerebrovascular Injury and TBI: Is it Safe and Effective? An EAST Multicenter Study. Am Surg. 2024 Jun;90(6):1330-1337. doi: 10.1177/00031348241230094. Epub 2024 Jan 22.
- Ali A, Broome JM, Tatum D, Abdullah Y, Black J, Tyler Simpson J, Salim A, Duchesne J, Taghavi S. Cost-Effectiveness of Universal Screening for Blunt Cerebrovascular Injury: A Markov Analysis. J Am Coll Surg. 2023 Mar 1;236(3):468-475. doi: 10.1097/XCS.0000000000000490. Epub 2022 Nov 28.
- Hemming K, Taljaard M, Marshall T, Goldstein CE, Weijer C. Stepped-wedge trials should be classified as research for the purpose of ethical review. Clin Trials. 2019 Dec;16(6):580-588. doi: 10.1177/1740774519873322.
- Biffl WL, Moore EE, Offner PJ, Brega KE, Franciose RJ, Burch JM. Blunt carotid arterial injuries: implications of a new grading scale. J Trauma. 1999 Nov;47(5):845-53. doi: 10.1097/00005373-199911000-00004.
- Paulus EM, Fabian TC, Savage SA, Zarzaur BL, Botta V, Dutton W, Croce MA. Blunt cerebrovascular injury screening with 64-channel multidetector computed tomography: more slices finally cut it. J Trauma Acute Care Surg. 2014 Feb;76(2):279-83; discussion 284-5. doi: 10.1097/TA.0000000000000101.
- Kim DY, Biffl W, Bokhari F, Brakenridge S, Chao E, Claridge JA, Fraser D, Jawa R, Kasotakis G, Kerwin A, Khan U, Kurek S, Plurad D, Robinson BRH, Stassen N, Tesoriero R, Yorkgitis B, Como JJ. Evaluation and management of blunt cerebrovascular injury: A practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2020 Jun;88(6):875-887. doi: 10.1097/TA.0000000000002668.
- Expert Panel on Major Trauma Imaging; Shyu JY, Khurana B, Soto JA, Biffl WL, Camacho MA, Diercks DB, Glanc P, Kalva SP, Khosa F, Meyer BJ, Ptak T, Raja AS, Salim A, West OC, Lockhart ME. ACR Appropriateness Criteria(R) Major Blunt Trauma. J Am Coll Radiol. 2020 May;17(5S):S160-S174. doi: 10.1016/j.jacr.2020.01.024.
- Schmidt JC, Huang DD, Fleming AM, Brockman V, Hennessy EA, Magnotti LJ, Schroeppel T, McFann K, Hamilton LD, Dunn JA. Missed blunt cerebrovascular injuries using current screening criteria - The time for liberalized screening is now. Injury. 2023 May;54(5):1342-1348. doi: 10.1016/j.injury.2023.02.019. Epub 2023 Feb 14.
- Othman Y, Nasef Y, Jayagopi K, Singh P, Prashar S, Elkbuli A. Universal computed tomography angiography screening for blunt cerebrovascular injury: a systematic review of improved detection, clinical outcomes, and cost-effectiveness. Emerg Radiol. 2026 Jun 8. doi: 10.1007/s10140-026-02495-x. Online ahead of print.
- Harper PR, Jacobson LE, Sheff Z, Williams JM, Rodgers RB. Routine CTA screening identifies blunt cerebrovascular injuries missed by clinical risk factors. Trauma Surg Acute Care Open. 2022 Aug 26;7(1):e000924. doi: 10.1136/tsaco-2022-000924. eCollection 2022.
- Tran A, Fernando SM, Rochwerg B, Hameed MS, Dawe P, Hawes H, Haut E, Inaba K, Engels PT, Zarychanski R, Siegal DM, Carrier M. Prognostic factors associated with venous thromboembolism following traumatic injury: A systematic review and meta-analysis. J Trauma Acute Care Surg. 2024 Sep 1;97(3):471-477. doi: 10.1097/TA.0000000000004326.
- Bruns BR, Tesoriero R, Kufera J, Sliker C, Laser A, Scalea TM, Stein DM. Blunt cerebrovascular injury screening guidelines: what are we willing to miss? J Trauma Acute Care Surg. 2014 Mar;76(3):691-5. doi: 10.1097/TA.0b013e3182ab1b4d.
- Burlew CC, Biffl WL, Moore EE, Barnett CC, Johnson JL, Bensard DD. Blunt cerebrovascular injuries: redefining screening criteria in the era of noninvasive diagnosis. J Trauma Acute Care Surg. 2012 Feb;72(2):330-5; discussion 336-7, quiz 539. doi: 10.1097/TA.0b013e31823de8a0.
- Biffl WL, Moore EE, Offner PJ, Brega KE, Franciose RJ, Elliott JP, Burch JM. Optimizing screening for blunt cerebrovascular injuries. Am J Surg. 1999 Dec;178(6):517-22. doi: 10.1016/s0002-9610(99)00245-7.
- Fabian TC, George SM Jr, Croce MA, Mangiante EC, Voeller GR, Kudsk KA. Carotid artery trauma: management based on mechanism of injury. J Trauma. 1990 Aug;30(8):953-61; discussion 961-3. doi: 10.1097/00005373-199008000-00003.
- Burlew CC, Sumislawski JJ, Behnfield CD, McNutt MK, McCarthy J, Sharpe JP, Croce MA, Bala M, Kashuk J, Spalding MC, Beery PR, John S, Hunt DJ, Harmon L, Stein DM, Callcut R, Wybourn C, Sperry J, Anto V, Dunn J, Veith JP, Brown CVR, Celii A, Zander TL, Coimbra R, Berndtson AE, Moss TZ, Malhotra AK, Hazelton JP, Linden K, West M, Alam HB, Williams AM, Kim J, Inaba K, Moulton S, Choi YM, Warren HL, Collier B, Ball CG, Savage S, Hartwell JL, Cullinane DC, Zielinski MD, Ray-Zack MD, Morse BC, Rhee P, Rutherford EJ, Udekwu P, Reynolds C, Toschlog E, Gondek S, Ju T, Haan JM, Lightwine KL, Kulvatunyou N, Coates B, Khouqeer AF, Todd SR, Zarzaur B, Waller CJ, Kallies KJ, Neideen T, Eddine SBZ, Peck KA, Dunne CE, Kramer K, Bokhari F, Dhillon TS, Galante JM, Cohen MJ. Time to stroke: A Western Trauma Association multicenter study of blunt cerebrovascular injuries. J Trauma Acute Care Surg. 2018 Nov;85(5):858-866. doi: 10.1097/TA.0000000000001989.
- Russo RM, Davidson AJ, Alam HB, DuBose JJ, Galante JM, Fabian TC, Savage S, Holcomb JB, Scalea TM, Rasmussen TE; AAST PROOVIT Study Group. Blunt cerebrovascular injuries: Outcomes from the American Association for the Surgery of Trauma PROspective Observational Vascular Injury Treatment (PROOVIT) multicenter registry. J Trauma Acute Care Surg. 2021 Jun 1;90(6):987-995. doi: 10.1097/TA.0000000000003127.
- Leichtle SW, Banerjee D, Schrader R, Torres B, Jayaraman S, Rodas E, Broering B, Aboutanos MB. Blunt cerebrovascular injury: The case for universal screening. J Trauma Acute Care Surg. 2020 Nov;89(5):880-886. doi: 10.1097/TA.0000000000002824.
- Black JA, Abraham PJ, Abraham MN, Cox DB, Griffin RL, Holcomb JB, Hu PJ, Kerby JD, Liptrap EJ, Thaci B, Harrigan MR, Jansen JO. Universal screening for blunt cerebrovascular injury. J Trauma Acute Care Surg. 2021 Feb 1;90(2):224-231. doi: 10.1097/TA.0000000000003010.
- Geddes AE, Burlew CC, Wagenaar AE, Biffl WL, Johnson JL, Pieracci FM, Campion EM, Moore EE. Expanded screening criteria for blunt cerebrovascular injury: a bigger impact than anticipated. Am J Surg. 2016 Dec;212(6):1167-1174. doi: 10.1016/j.amjsurg.2016.09.016. Epub 2016 Sep 29.
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- INOVA-2026-299
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