AI Assistance for Detecting Active Bleeding During DSA Procedures

N/ANot Yet RecruitingNCT07824739

Zhongda Hospital1,324 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,324

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint

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.