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

January 12, 2026 updated by: Hong Liu, Nanjing Medical University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Anzhen Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai East Hospital Tongji University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UT Group
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) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery
Active Comparator: Control Group
Ulinastatin (100000U TID for 5 days) immediately after surgery
Drug: Ulinastatin only
Ulinastatin (100000U TID for 5 days) immediately after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
Time Frame: within the prior 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.
within the prior 7 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

West China Hospital
Beijing Anzhen Hospital
The First Affiliated Hospital of Guangzhou Medical University
Shanghai East Hospital,Tongji University School of Medicine

Investigators

  • Study Director: Yong-feng Shao, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 4, 2025

First Submitted That Met QC Criteria

May 4, 2025

First Posted (Actual)

May 13, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA XI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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