An interventional study of Ulinastatin and Thymosin α1 and Ulinastatin only in Aortic Dissection and Aortic Dissection Aneurysm, sponsored by Nanjing Medical University. Enrolling by invitation at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Prevention
Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha
1 in addition to antiinflammatory treatment may be beneficial. This study was designed to test the hypothesis that the administration of Ulinastatin and Thymosin α1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 200 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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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.
Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery
Drug: Ulinastatin and Thymosin α1
Ulinastatin (100000U TID for 5 days) immediately after surgery
Drug: Ulinastatin only
Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery
Ulinastatin (100000U TID for 5 days) immediately after surgery
The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
The occurrence of new-onset organ failure and new-onset persistent organ failure (Sequential Organ Failure Assessment (SOFA) score. New-onset is defined as events that occur after randomization and not present 24 hours before randomization.
Time frame: within the prior 7 days after surgery.
Plan to share: Undecided
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
Of 49 interventional studies with no phase under Aortic Dissection, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23. This study's planned 20 months is below that.
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