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

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

Interventions

DRUG

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

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.

DRUG

Blank control

Blank control

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Nanjing First Hospital, Nanjing Medical University

  collaborator OTHER

• Shanghai East Hospital,Tongji University School of Medicine

  collaborator UNKNOWN

• The Seventh Affiliated Hospital of Xinjiang Medical University

  collaborator UNKNOWN

• TEDA International Cardiovascular Hospital

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Nanjing Medical University

  lead OTHER

Principal Investigators

• Hong Liu · Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations