By InvitationNot Applicable

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

China200 participantsStarted 2025-04-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset; * Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled. * The patients' age between 18 \~90 years old. * Agree to participate in the study and sign the informed consent. Exclusion Criteria: * Patients allergic to Thymosin α1 or Ulinastatin; * Lactating women and pregnant women; * Patients with mental diseases, drug and alcohol dependence; * Refuse to participate in this study and refuse to sign the informed consent.

What they're measuring

The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery

Timeframe: within the prior 7 days after surgery.

Trial details

NCT IDNCT06966687

SponsorNanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31