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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ulinastatin and Thymalfasin

    Drug

    AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy

  • Ulinastatin

    Drug

    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 with infection, combined antibiotic therapy will be given; for patients with normal or slightly elevated inflammatory indicators, anti-inflammatory drugs may be temporarily withheld, and close monitoring will be performed instead. The regimen will be adjusted according to changes in routine inflammatory indicators after surgery until the patient is discharged.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Subtyping-based precision therapyExperimental treatment 1 intervention
Group B: Conventional Empirical StrategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

The Third Affiliated Hospital of Soochow University

Collaborator

West China Hospital

Collaborator

Fujian Medical University Union Hospital

Collaborator

Shanghai East Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator

Second Affiliated Hospital of Nanchang University

Collaborator

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