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Not yet recruiting NCT07382375

AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection

No phase Interventional Aortic Aneurysm and Dissection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ulinastatin and Thymalfasin, Ulinastatin.
Who it may be relevant to
Registry conditions: Aortic Aneurysm and Dissection. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

AI-assisted Immunoinflammatory Subtyping-Directed Precision Treatment in Acute Aortic Dissection: A Multicenter RCT-based Exploration

Overview

Aortic dissection has acute onset and high mortality, with immunoinflammatory response driving lesion progression. Current perioperative anti-inflammatory therapies are mostly empirical and poorly targeted, and AI-assisted typing lacks a complete clinical translation pathway. This study integrates multi-dimensional data to construct an AI immunoinflammatory subtyping system, enabling rapid subtyping and establishing a "subtyping-target-treatment" closed loop for emergency needs. Using a prospective multicenter RCT, 300 patients are randomly divided into two groups: the experimental group receives subtyping-based precision therapy, while the control group uses empirical strategies (treatment of physician's choice). It observes 7-day postoperative SOFA score, SIRS and other prognostic indicators to provide evidence-based support for precision treatment.

Interventions

  • Drug Ulinastatin and Thymalfasin
    AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy
  • Drug Ulinastatin
    Conventional empirical regimens will be formulated based on patients' clinical symptoms and routine inflammatory indicators (white blood cell count, C-reactive protein, procalcitonin) without uniform target-matching standards, with reference to clinical diagnosis and treatment guidelines: if obvious inflammatory responses are present (e.g., fever, significant elevation of C-reactive protein), non-steroidal anti-inflammatory drugs or low-dose glucocorticoids will be administered; if complicated w

Primary outcome measures

  • Sequential Organ Failure Assessment (SOFA) score. The SOFA score evaluates 6 organ systems, ranging from 0, no dysfunction, to 4, failure, and the total score ranges from 0, normal, to 24, most severe form of multiorgan failure. [Time frame: 7 days after surgery]

Eligibility criteria

Inclusion criteria

  • Confirmed diagnosis of acute aortic dissection by contrast-enhanced Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA);
  • Planned emergency surgical treatment (including open surgery and endovascular repair);
  • Aged 18-80 years old, regardless of gender;
  • Time from onset to hospital admission ≤ 72 hours;
  • Signed informed consent form by the patient or their authorized agent, with willingness to cooperate with the follow-up of the study.

Exclusion criteria

  • Complicated with underlying diseases that affect immunoinflammatory status, such as severe infections (e.g., sepsis, infective endocarditis), autoimmune diseases, malignant tumors, chronic liver diseases, and chronic kidney diseases (uremic stage);
  • Long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);
  • Pregnant or lactating women;
  • Patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 8 centers
  • Beijing Anzhen Hospital — Beijing
  • Changzhou First People Hospital — Changzhou
  • West China Hospital of Sichuan University — Chengdu
  • Fujian Medical University Union Hospital — Fuzhou
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Nanchang University Second Hospital — Nanchang
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing
  • Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT07382375 · PANDA-Smart

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗