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.
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.
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.
Parallel
Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
DrugThymosin 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.
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DrugBlank control
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.
30-day mortality
Death from any cause of 30 days after randomization
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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
