AI Assistance for Detecting Active Bleeding During DSA Procedures
Real-Time DSA-VDet Assistance for Detecting Active Bleeding Across Multiple Anatomical Regions: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Controlled Trial
Clinically, DSA-VDet can continuously indicate suspected bleeding regions throughout a complete angiographic sequence and provide a second-reader opinion to the operator. It is expected to reduce the time required for frame-by-frame review and localization of culprit vessels, reduce missed detection of small, multiple, or unusually located bleeding sites, and improve consistency among physicians with different levels of experience. Faster culprit-vessel localization may also reduce repeat angiography, radiation exposure, and unnecessary superselective catheterization. These potential benefits will be tested in the prospective randomized trial; the study does not assume that the model will necessarily improve clinical outcomes. From a translational perspective, the study will establish a standardized temporal DSA database spanning multiple centers, devices, and anatomical regions, together with bleeding-site annotation standards, a model suitable for real-time deployment, and a pathway for clinical evaluation. These resources may provide a reproducible technical foundation for regional collaboration in emergency interventional care and AI-assisted interpretation in lower-resource hospitals.
The core value of this study is therefore to address the 'single-region, weak-temporal, algorithm-centered, clinically under-evaluated' limitations of existing models. Using multicenter DSA videos from multiple anatomical regions, the study will leverage contrast kinetics and motion information to improve detection of small bleeding sites and will progress from retrospective validation through controlled physician interpretation to a prospective randomized trial, providing a continuous evaluation from technical performance to clinical benefit.
調査の概要
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：Jian Lu
- 電話番号：13616106021
- メール：lujian43307131@126.com
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、213003
- Zhongda hospital
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コンタクト：
- Jun-Hao Mei
- 電話番号：15052007938
- メール：jh_mei240225@126.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- age 18 years or older;
- suspected acute active bleeding in an intracranial, solid-organ, pelvic, gastrointestinal, respiratory, great-vessel, or other relevant anatomical region requiring DSA-guided interventional diagnosis or treatment;
- clinical suitability for the planned DSA procedure;
- written informed consent from the patient or legally authorized representative before randomization whenever feasible, or eligibility for an ethics-approved deferred-consent pathway at an activated site when prior consent is impossible and treatment cannot be delayed.
Exclusion Criteria:
- a history of severe allergic reaction to iodinated contrast medium or related medications that precludes the planned procedure;
- severe coagulopathy or a platelet count below 50x10^9/L when interventional treatment is considered clinically inappropriate;
- severe cardiac or pulmonary insufficiency that makes the planned procedure unsafe;
- pregnancy or breastfeeding;
- severe renal insufficiency or another condition that may substantially increase interventional risk;
- inability to complete angiography safely according to the required workflow despite clinically appropriate support;
- any other circumstance that, in the investigator's judgment, makes participation unsuitable. Impaired decision-making capacity alone will not be an exclusion if consent can be obtained from a legally authorized representative or through the ethics-approved deferred-consent pathway.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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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実験的：DSA-VDet-assisted group
During DSA acquisition, DSA-VDet v1.0 will perform continuous frame-by-frame inference and continuously display suspected bleeding regions, confidence scores, and relevant frame indices.
The operator will retain responsibility for the final diagnosis, selection of culprit vessels, and all angiographic and embolization decisions.
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During DSA acquisition, DSA-VDet v1.0 will perform continuous frame-by-frame inference and continuously display suspected bleeding regions, confidence scores, and relevant frame indices.
The operator will retain responsibility for the final diagnosis, selection of culprit vessels, and all angiographic and embolization decisions.
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介入なし：Conventional-interpretation group
The operator will perform frame-by-frame interpretation using the conventional DSA equipment and established workflow, without access to DSA-VDet output.
Images may undergo offline model analysis after completion of the index procedure for exploratory purposes, but those results must not be available for the index clinical decision.
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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 |
|---|---|---|
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the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
時間枠：Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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To determine whether real-time DSA-VDet v1.0 assistance shortens the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint, compared with conventional interpretation.
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Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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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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the detection and localization performance of DSA-VDet
時間枠：Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
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Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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effects on interpretation accuracy
時間枠：Upon achievement of the correct diagnostic endpoint, an average of 1 hour
|
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
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Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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interpretation time
時間枠：Upon achievement of the correct diagnostic endpoint, an average of 1 hour
|
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
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Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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interobserver agreement among interventional physicians with different levels of experience
時間枠：Upon achievement of the correct diagnostic endpoint, an average of 1 hour
|
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
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Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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協力者と研究者
スポンサー
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DSA-VDet
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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