Aortic Aneurysm and DissectionNCT07382375
AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection
A study testing Ulinastatin and Thymalfasin and Ulinastatin in people with Aortic Aneurysm and Dissection, run by Nanjing Medical University at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Aneurysm and Dissection
- What is being tested?
- Ulinastatin and Thymalfasin and Ulinastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesChina
- Study dates
- 31 Dec 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of acute aortic dissection by contrast-enhanced Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA);
- Planned emergency surgical treatment (including open surgery and endovascular repair);
- Aged 18-80 years old, regardless of gender;
- Time from onset to hospital admission ≤ 72 hours;
- Signed informed consent form by the patient or their authorized agent, with willingness to cooperate with the follow-up of the study.
Who cannot join
- 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);
- Long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);
- Pregnant or lactating women;
- Patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guo-laing Fan, MD contact
8 sites in 1 country
China8 sites
Beijing Anzhen Hospital
Beijing
Si-chong Qian, MD, 18801281613, drqsc1990a@163.com
Hai-yang Li
Changzhou First People Hospital
Changzhou
Chao Ma, MD, 15851983609, machaomain@163.com
Chao Ma, MD
West China Hospital of Sichuan University
Chengdu
Hong-hua YUE, MD, 13281130798, yuecqmu@163.com
Zhong Wu, MD
Fujian Medical University Union Hospital
Fuzhou
Dong-dong Wu, MD, 17759515390, 734223972@qq.com
Dong-dong Wu, MD
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Ying-yuan Zhang, 13662378847@139.com
KAI WANG
Nanchang University Second Hospital
Nanchang
Ji-sheng Zhong, MD, 13502153976, 837966728@qq.com
Ji-sheng Zhong, MD
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Sheng Zhao, 18801281613, zhaosheng0824@njmu.edu.cn
Yong-feng Shao
Shanghai East Hospital
Shanghai
Guo-liang Fan, smartmanliang@sina.com
Hai-tao Zhang, MD
About this study
Official title: AI-assisted Immunoinflammatory Subtyping-Directed Precision Treatment in Acute Aortic Dissection: A Multicenter RCT-based Exploration
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
- Being tested
- Ulinastatin and Thymalfasin, Ulinastatin
- Keywords
- inflammation, immune
- Medical subject headings
- Aortic Dissection, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulinastatin and ThymalfasinDrug
AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy
UlinastatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Subtyping-based precision therapy | Experimental | * 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. Receives: Drug: Ulinastatin and Thymalfasin |
| Conventional Empirical Strategy | Active comparator | treatment of physician's choice alone Receives: Drug: Ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start31 Dec 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm and DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The 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
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Yong-feng Shao, Study director, The First Affiliated Hospital with Nanjing Medical UniversityHong Liu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382375
- Sponsor's protocol ID
- PANDA-Smart
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-assisted Immunoinflammatory Subtyping-Directed Precision Treatment in Acute Aortic Dissection: A Multicenter RCT-based Exploration
- ClinicalTrials.gov ID
- NCT07382375
- Acronym / sponsor ID
- PANDA-Smart
- Conditions
- Aortic Aneurysm and Dissection
- Keywords
- inflammation, immune
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The 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 start
- 31 Dec 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtyping-based precision therapy | Experimental | Drug: Ulinastatin and Thymalfasin* 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. |
| Conventional Empirical Strategy | Active comparator | Drug: Ulinastatintreatment of physician's choice alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of acute aortic dissection by contrast-enhanced Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA);
- Planned emergency surgical treatment (including open surgery and endovascular repair);
- Aged 18-80 years old, regardless of gender;
- Time from onset to hospital admission ≤ 72 hours;
- Signed informed consent form by the patient or their authorized agent, with willingness to cooperate with the follow-up of the study.
Key exclusion criteria (4 listed)
- 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);
- Long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);
- Pregnant or lactating women;
- Patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulinastatin and ThymalfasinAI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy | Drug | Subtyping-based precision therapy |
| UlinastatinConventional 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. | Drug | Conventional Empirical Strategy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo-laing Fan, MD contact
Yong-feng Shao study director
The First Affiliated Hospital with Nanjing Medical University
Hong Liu principal investigator
The First Affiliated Hospital with Nanjing Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin and Thymalfasin and Ulinastatin in people with Aortic Aneurysm and Dissection, run by Nanjing Medical University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Zhao (18801281613, zhaosheng0824@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.