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AI Assistance for Detecting Active Bleeding During DSA Procedures

11 september 2026 uppdaterad av: Jian Lu, Zhongda Hospital

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1324

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 213003

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: DSA-VDet v1.0
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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
Tidsram: 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.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the detection and localization performance of DSA-VDet
Tidsram: 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.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour
effects on interpretation accuracy
Tidsram: 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.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour
interpretation time
Tidsram: 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.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour
interobserver agreement among interventional physicians with different levels of experience
Tidsram: 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.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Zhongda Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

30 december 2027

Studieregistreringsdatum

Först inskickad

2 september 2026

Först inskickad som uppfyllde QC-kriterierna

11 september 2026

Första postat (Faktisk)

17 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • DSA-VDet

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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