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

NCT06966687 | Enrolling By Invitation DMC

• 1 other identifier: PANDA XI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Aortic Dissection; inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  within the prior 7 days after surgery.

Study Arms (2)

UT Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Drug: Ulinastatin only

Interventions

Ulinastatin and Thymosin α1 DRUG

Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery

UT Group

Ulinastatin only DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• West China Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Shanghai East Hospital,Tongji University School of Medicine: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (4)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Shanghai East Hospital Tongji University

Shanghai, Shanghai Municipality, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

Related Publications (1)

• Liu D, Yu Z, Yin J, Chen Y, Zhang H, Xin F, Fu H, Wan B. Effect of ulinastatin combined with thymosin alpha1 on sepsis: A systematic review and meta-analysis of Chinese and Indian patients. J Crit Care. 2017 Jun;39:259-266. doi: 10.1016/j.jcrc.2016.12.013. Epub 2016 Dec 27.

  PMID: 28069319 RESULT

MeSH Terms

Conditions

Aortic Dissection; Inflammation

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong-feng Shao

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (4)