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

NCT05339529 | Completed DMC

• 1 other identifier: PANDA II
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 15

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 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.

Conditions

Acute Aortic Syndrome; Aortic Dissection Type A

Outcome Measures

Primary Outcomes (1)

• 7-day postoperative organ dysfunction burden assessed by mean daily SOFA score

  The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys

  7 days after surgery

Secondary Outcomes (1)

• 30-day mortality

  30 days after randomization

Study Arms (2)

Thymosin alpha 1

EXPERIMENTAL

1.6 mg q12h for 5 days

Drug: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-

Blank control

OTHER

Standard care control; no placebo or sham thymosin alpha 1 injections were administered.

Drug: Blank control

Interventions

Blank control DRUG

Blank control (Standard care control; no placebo or sham thymosin alpha 1 injections were administered.)

Blank control

Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- DRUG

Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead.

Thymosin alpha 1

Eligibility Criteria

• Age: 18 Years - 90 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;
• 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
• Beijing Anzhen Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Nanjing First Hospital, Nanjing Medical University: collaborator
• The Seventh Affiliated Hospital of Xinjiang Medical University: collaborator
• TEDA International Cardiovascular Hospital: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• West China Hospital: collaborator
• Shanghai East Hospital of Tongji University: collaborator

Study Sites (15)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Nanjing First Hospital Nanjing Medical University

Nanjing, Jiangsu, China

Location

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

The Friendship Hospital of Yili Kazak Autonomous Prefecture

Kazak, Xinjiang, China

Location

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Beijing Anzhen Hospital Capital Medical University

Beijing, 10029, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Shanghai East Hospital Tongji University

Shanghai, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

Related Publications (1)

• Liu H, Qian SC, Zhang YY, Tang CB, Yue HH, Fan GL, Zhao X, Jiang YY, Huang FH, Zeng ZH, Wang W, Lu XR, Luo XK, Bai XF, Zheng XX, Xie P, Ma C, Zhao S, Zhang HJ; On the behalf of China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A) and PANDA Trial Investigators. Effect of thymosin alpha1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol. Future Cardiol. 2025 Jun;21(7):447-454. doi: 10.1080/14796678.2025.2505401. Epub 2025 May 14.

  PMID: 40367062 DERIVED

MeSH Terms

Conditions

Acute Aortic Syndrome

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Hong Liu

  Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking was role specific. Participants were not informed of treatment allocation. Treating ICU physicians were not involved in randomization or study-drug prescription but could potentially ascertain allocation from electronic medication records and were therefore not considered formally masked. Nursing personnel were not uniformly masked. Independent SOFA outcome assessors were unaware of treatment allocation. Flow-cytometry and biomarker personnel and statisticians were also unaware of allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Cardiovascular Surgery

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 21, 2022
• Study Start: July 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

CN (15)