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
Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
Status
Enrolling by invitation
Phase
Not applicable
Enrollment
200
Locations
4
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Ulinastatin only
Ulinastatin (100000U TID for 5 days) immediately after surgery
Timeline
From registration to results.
First posted
May 13, 2025
Study start
Apr 1, 2025
Primary completion
Dec 31, 2026
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
Jan 14, 2026
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
4 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shanghai East Hospital Tongji University
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Publications
Results and literature.
Related trials
More studies on Thymosin Alpha-1.
NCT IDStudyPhase / statusEnrollmentUpdated
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
The Methodist Hospital Research Institute · Vaccine Response · COVID-19 Vaccine
Phase 1
Recruiting
75
2026-07
Thymosin-α1 for Recurrent Implantation Failure
Fakih IVF Fertility Center · Recurrent Implantation Faliure
Phase 2 / Phase 3
Recruiting
136
2026-06
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
Beijing Friendship Hospital · Colorectal Neoplasms
Not applicable
Completed
47
2026-06
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Sun Yat-sen University · Melanoma · Immune-related Adverse Event
Phase 2
Recruiting
55
2026-06
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
Fudan University · Esophageal Squamous Cell Carcinoma
Not applicable
Active, not recruiting
50
2026-04
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
William B. Ershler, MD · COVID-19
Phase 2
Completed
189
2026-04
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
The First Affiliated Hospital with Nanjing Medical University · Gastric Cancer
Phase 2
Recruiting
48
2026-03
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
Zekuan Xu · Gastric Cancer · Esophagogastric Junction Adenocarcinoma
Phase 2
Recruiting
30
2026-03
Related PeptideStat pages
Put the record in context.
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