An interventional study of Ulinastatin and Thymalfasin and Ulinastatin in Aortic Aneurysm and Dissection, sponsored by Nanjing Medical University. Not yet recruiting at 8 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Prevention
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.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 300 is above the median of 114 across 86 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
Drug: Ulinastatin and Thymalfasin
treatment of physician's choice alone
Drug: Ulinastatin
Drug pages: Urinastatin · Thymalfasin
AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy
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.
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.
Time frame: 7 days after surgery
Plan to share: No
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Studies of the drugs tested here: Urinastatin · Thymalfasin