• Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)

  NCT06966687

  Enrolling by invitationInterventionalNot ApplicableUpdated Jan 14, 2026
• Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Cohort Study) III

  NCT04918108

  CompletedObservationalUpdated Nov 20, 2024
• AI-Guided Intensified Follow-up After Surgery for Acute Type A Aortic Dissection

  NCT07623213

  Not yet recruitingInterventionalNot ApplicableUpdated Jun 3, 2026
• Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)

  NCT04711889

  CompletedInterventionalNot ApplicableUpdated Dec 13, 2024
• Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection

  NCT01894334

  Unknown statusInterventionalNot ApplicableUpdated Jan 24, 2014
• sirA-CPB Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery

  NCT07750548

  Not yet recruitingInterventionalNot ApplicableUpdated Aug 6, 2026

ClinicalTrials.gov ID

NCT07382375

Lead Sponsor

Nanjing Medical UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

300Estimated

Last Update Posted

Feb 2, 2026Actual

Start Date

Dec 31, 2027Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

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

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.

• Aortic Aneurysm and Dissection

• Ulinastatin and Thymalfasin
• Ulinastatin

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Nanjing Medical UniversityOTHER

Collaborators

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

The Third Affiliated Hospital of Soochow UniversityOTHER

West China HospitalOTHER

Fujian Medical University Union HospitalOTHER

Shanghai East HospitalOTHER

Beijing Anzhen HospitalOTHER

Second Affiliated Hospital of Nanchang UniversityOTHER

machaomain@163.com15851983609

yuecqmu@163.com13281130798

734223972@qq.com17759515390

837966728@qq.com13502153976

smartmanliang@sina.com