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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Stefan W Leichtle, MD, MBA
- 電話番号：(703) 776-2274
- メール：stefan.leichtle@inova.org
研究連絡先のバックアップ
- 名前：Catherine Zwemer, MD
- 電話番号：(703) 776-2274
- メール：cathzwemer@gmail.com
研究場所
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Virginia
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Falls Church、Virginia、アメリカ、22042
- Inova Health System
-
コンタクト：
- Stefan W Leichtle, MD, MBA
- 電話番号：703-776-2274
- メール：stefan.leichtle@inova.org
-
コンタクト：
- Catherine Zwemer, MD
- 電話番号：(703) 776-2274
- メール：Catherine.Zwemer@inova.org
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主任研究者：
- Stefan Leichtle, MD, MBA
-
副調査官：
- Stephen Varga, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with BCVI-related Ischemic Stroke
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of BCVI-Related Stroke per 1000 Major Blunt Trauma Admissions
時間枠：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
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Antithrombotic-related bleeding
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Stefan W Leichtle, MD, MBA、Inova Health Care Services
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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