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

Nanjing Medical University

Status: Begins enrollment in a year or more

Conditions: Aortic Aneurysm and Dissection

Treatments: Drug: Ulinastatin and Thymalfasin; Drug: Ulinastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07382375

PANDA-Smart

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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);
2. Long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);
3. Pregnant or lactating women;
4. Patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Subtyping-based precision therapy

Experimental group

Description:

* Balanced type (HIS1): No anti-inflammatory intervention required; * Inflammation-excessive type (HIS2): Anti-inflammatory intervention with ulinastatin; ③ Immunosuppressive type (HIS3): Immunomodulation with thymalfasin; ④ Mixed reaction type (HIS4): Combined treatment with ulinastatin and thymalfasin.

Treatment:

Drug: Ulinastatin and Thymalfasin

Conventional Empirical Strategy

Active Comparator group

Description:

treatment of physician's choice alone

Treatment:

Drug: Ulinastatin