Aortic Aneurysm and Dissection
Conditions
Keywords
inflammation, immune
Brief 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.
Interventions
DRUGUlinastatin and Thymalfasin
AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy
DRUGUlinastatin
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.
Sponsors
Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
Third Affiliated Hospital of Soochow University
West China Hospital
Fujian Medical University Union Hospital
Shanghai East Hospital
Beijing Anzhen Hospital
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
China
Contacts
CONTACTSheng Zhao
CONTACTGuo-laing Fan, MD
STUDY_DIRECTORYong-feng Shao
The First Affiliated Hospital with Nanjing Medical University
PRINCIPAL_INVESTIGATORHong Liu
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed