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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

330 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing Medical University

Lead sponsor

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