Cerebrovascular TraumaPRaCTUS BCVINCT07919847
Universal Screening for Blunt Cerebrovascular Injury
A study testing Selective Screening and Universal Screening in people with Cerebrovascular Trauma, run by Inova Health Care Services at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebrovascular Trauma
- What is being tested?
- Selective Screening and Universal Screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Transferred patients
- Prisoners
- Age less than 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Inova Health System
Falls Church, Virginia, 22042
Stefan W Leichtle, MD, MBA, 703-776-2274, stefan.leichtle@inova.org
Catherine Zwemer, MD, (703) 776-2274, Catherine.Zwemer@inova.org
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Cerebrovascular Trauma
- Being tested
- Selective Screening, Universal Screening
- Keywords
- cerebrovascular trauma
- Medical subject headings
- Cerebrovascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective ScreeningProcedure or surgery
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.
Universal ScreeningProcedure or surgery
Screening all adult major blunt trauma patients with CTA of the neck.
| Study group | Role | What they receive |
|---|---|---|
| Selective Screening | Active comparator | 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. Receives: Procedure: Selective Screening |
| Universal Screening | Active comparator | Participating institution assigned to perform universal screening all adult major blunt trauma patients with CTA of the neck. Receives: Procedure: Universal Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition
Secondary outcomes (2)
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.
Measured: 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.
Measured: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a pragmatic, stepped-wedge cluster randomized trial. The decision whether to screen major blunt trauma patients for BCVI using defined criteria (SS) or universally (US) with neck CTA is one made on the level of the TC, not the individual patient. Therefore, the unit of randomization will be the trauma center (the cluster). All centers at baseline will begin in the SS (control) condition, and at fixed intervals (every two months), randomly selected centers will cross over to universal screening of all major blunt trauma activations and remain in this group. The trial will conclude when every center has switched and concluded, i.e., after 12 months.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for the Surgery of Trauma
- Responsible party
- Sponsor
- Investigators
- Stefan W Leichtle, MD, MBA, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919847
- Sponsor's protocol ID
- INOVA-2026-299
- Acronym
- PRaCTUS BCVI
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data will be shared.
Publications
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.
PubMed 38253324Shahan 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.
PubMed 27027559Ali 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.
PubMed 36440860Hemming 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.
PubMed 31818147Weijer 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.
PubMed 23185138Biffl 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.
PubMed 10568710Paulus 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.
PubMed 24458034Kim 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.
PubMed 32176167Expert 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.
PubMed 32370960Schmidt 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.
PubMed 36841698Othman 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.
PubMed 42258110Harper 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.
PubMed 36101794Tran 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.
PubMed 38548736Bruns 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.
PubMed 24553535Burlew 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.
PubMed 22327974
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Clinical Trial of Universal Screening for BCVI
- ClinicalTrials.gov ID
- NCT07919847
- Acronym / sponsor ID
- PRaCTUS BCVI / INOVA-2026-299
- Conditions
- Cerebrovascular Trauma
- Keywords
- cerebrovascular trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- American Association for the Surgery of Trauma
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic, stepped-wedge cluster randomized trial. The decision whether to screen major blunt trauma patients for BCVI using defined criteria (SS) or universally (US) with neck CTA is one made on the level of the TC, not the individual patient. Therefore, the unit of randomization will be the trauma center (the cluster). All centers at baseline will begin in the SS (control) condition, and at fixed intervals (every two months), randomly selected centers will cross over to universal screening of all major blunt trauma activations and remain in this group. The trial will conclude when every center has switched and concluded, i.e., after 12 months.
| Arm | Type | Receives |
|---|---|---|
| Selective Screening | Active comparator | Procedure: Selective ScreeningParticipating 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. |
| Universal Screening | Active comparator | Procedure: Universal ScreeningParticipating institution assigned to perform universal screening all adult major blunt trauma patients with CTA of the neck. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Transferred patients
- Prisoners
- Age less than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective ScreeningScreening 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. | Procedure or surgery | Selective Screening |
| Universal ScreeningScreening all adult major blunt trauma patients with CTA of the neck. | Procedure or surgery | Universal Screening |
Primary outcome
Number of Participants with BCVI-related Ischemic Stroke
Time frame: 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.
2 secondary outcomes
Incidence of BCVI-Related Stroke per 1000 Major Blunt Trauma Admissions
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
Time frame: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 38253324Kelley 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.
- Background: PubMed 27027559Shahan 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.
- Background: PubMed 36440860Ali 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.
- Background: PubMed 31818147Hemming 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.
- Background: PubMed 23185138Weijer 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.
- Background: PubMed 10568710Biffl 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.
- Background: PubMed 24458034Paulus 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.
- Background: PubMed 32176167Kim 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.
- Background: PubMed 32370960Expert 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.
- Background: PubMed 36841698Schmidt 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.
- Background: PubMed 42258110Othman 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.
- Background: PubMed 36101794Harper 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.
- American College of Surgeons. ACS Best Practices Guidelines: The Management of Traumatic Brain Injury.Link provided by the sponsor.
- American College of Surgeons. Resources for Optimal Care of the Injured Patient (2022 Standards).Link provided by the sponsor.
- Individual participant dataSharing planned: No. No individual patient data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan W Leichtle, MD, MBA principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Screening and Universal Screening in people with Cerebrovascular Trauma, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan W Leichtle, MD, MBA ((703) 776-2274, stefan.leichtle@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with BCVI-related Ischemic Stroke (time frame: In-hospital, from admission to discharge or in-hospital death; aggregated over the 12-month data-collection period by screening condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919847, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.