Real-Time DSA-VDet Assistance for Detecting Active Bleeding Across Multiple Anatomical Regions: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,324
- 试验地点
- 1
- 主要终点
- the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The randomized trial will use a prospective randomized open, blinded-endpoint (PROBE) design. Operators and participants will be aware of allocation. The independent outcome adjudicators, image reviewers performing endpoint verification, and statistical analysts will remain blinded to allocation until the database is locked and the primary analysis is finalized. System maintenance personnel who know the allocation will not participate in outcome adjudication or statistical analysis. Any inadvertent unblinding of a blinded reviewer will be documented and the affected assessment will be reassigned whenever feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: DSA-VDet v1.0 (Device)
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.
结局指标
主要结局
the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
时间窗: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
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.
次要结局
- the detection and localization performance of DSA-VDet(Upon achievement of the correct diagnostic endpoint, an average of 1 hour)
- effects on interpretation accuracy(Upon achievement of the correct diagnostic endpoint, an average of 1 hour)
- interpretation time(Upon achievement of the correct diagnostic endpoint, an average of 1 hour)
- interobserver agreement among interventional physicians with different levels of experience(Upon achievement of the correct diagnostic endpoint, an average of 1 hour)
研究者
Jian Lu
Principal Investigator
Zhongda Hospital