Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05339529

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Aortic Syndrome Aortic Diseases Aortic Dissection Type A Cardiovascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

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.

Blank control

Drug

Blank control

Primary outcomes

  1. The highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery

    Time frame: 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

  1. 30-day mortality

    Time frame: 30 days after randomization

    Death from any cause of 30 days after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

8618801281613

Hong-jia Zhang, MD

CONTACT

[email protected]

8601068303105

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

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

Registry information

Acronym: PANDA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.