Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)

NCT05339529 | Recruiting DMC

• 1 other identifier: PANDA II
• Study Type: interventional
• Target: 330
• 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)

• The highest 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.

  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

SHAM COMPARATOR

Drug: Blank control

Interventions

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

Blank control DRUG

Blank control

Blank control

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
• Shanghai East Hospital,Tongji University School of Medicine: 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

Study Sites (15)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Nanjing First Hospital Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

The Friendship Hospital of Yili Kazak Autonomous Prefecture

Kazak, Xinjiang, China

RECRUITING

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

Beijing Anzhen Hospital Capital Medical University

Beijing, 10029, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Shanghai East Hospital Tongji University

Shanghai, China

RECRUITING

TEDA International Cardiovascular Hospital

Tianjin, China

RECRUITING

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

Central Study Contacts

Hong Liu, MD

CONTACT

8618801281613; DR.HONGLIU@FOXMAIL.COM

Hong-jia Zhang, MD

CONTACT

8601068303105; zhanghongjia722@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (15)