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

NCT06966687 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Aortic Dissection
  • Aortic Dissection Aneurysm

Interventions

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

DRUG

Ulinastatin only

Ulinastatin (100000U TID for 5 days) immediately after surgery

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Shanghai East Hospital,Tongji University School of Medicine

    collaborator UNKNOWN

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • Yong-feng Shao · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966687 on ClinicalTrials.gov