NCT07382375

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Aneurysm and Dissection

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2027-12-31
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

8 sites across 1 country: China