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NCT07382375·Not applicable·INTERVENTIONAL

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

Thymosin Alpha-1InflammationNot yet recruiting

Status

Not yet recruiting

Phase

Not applicable

Enrollment

300

Locations

8

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Feb 2, 2026

  2. Study start

    Dec 31, 2027

  3. Primary completion

    Dec 31, 2027

  4. Study completion

    Dec 31, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Feb 2, 2026

Outcomes

What the study measures.

Primary outcomes

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

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

8 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Beijing Anzhen Hospital

Beijing, China

Changzhou First People Hospital

Changzhou, China

West China Hospital of Sichuan University

Chengdu, China

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Nanchang University Second Hospital

Nanchang, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Shanghai East Hospital

Shanghai, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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