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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jian Lu
- 电话号码:13616106021
- 邮箱:lujian43307131@126.com
学习地点
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Jiangsu
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Nanjing、Jiangsu、中国、213003
- Zhongda hospital
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接触:
- Jun-Hao Mei
- 电话号码:15052007938
- 邮箱:jh_mei240225@126.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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无干预: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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the detection and localization performance of DSA-VDet
大体时间: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
大体时间: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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interpretation time
大体时间: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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interobserver agreement among interventional physicians with different levels of experience
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DSA-VDet
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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