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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Stefan W Leichtle, MD, MBA
- 전화번호: (703) 776-2274
- 이메일: stefan.leichtle@inova.org
연구 연락처 백업
- 이름: Catherine Zwemer, MD
- 전화번호: (703) 776-2274
- 이메일: cathzwemer@gmail.com
연구 장소
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Virginia
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Falls Church, Virginia, 미국, 22042
- Inova Health System
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연락하다:
- Stefan W Leichtle, MD, MBA
- 전화번호: 703-776-2274
- 이메일: stefan.leichtle@inova.org
-
연락하다:
- Catherine Zwemer, MD
- 전화번호: (703) 776-2274
- 이메일: Catherine.Zwemer@inova.org
-
수석 연구원:
- Stefan Leichtle, MD, MBA
-
부수사관:
- Stephen Varga, MD
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with BCVI-related Ischemic Stroke
기간: 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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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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of BCVI-Related Stroke per 1000 Major Blunt Trauma Admissions
기간: From hospital admission until hospital discharge or in-hospital death, whichever occurs first (up to 14 days)
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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
기간: 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 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)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Antithrombotic-related bleeding
기간: During the hospitalization for the traumatic event, up to 14 days
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Incidence of antithrombotic-related bleeding events |
During the hospitalization for the traumatic event, up to 14 days
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BCVI detection rate
기간: 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
기간: 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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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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stefan W Leichtle, MD, MBA, Inova Health Care Services
간행물 및 유용한 링크
일반 간행물
- 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.
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- 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.
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- 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.
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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- INOVA-2026-299
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
No individual patient data will be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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