Acute Aortic Syndrome, Aortic Dissection Type a
Conditions
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.
Interventions
DRUGThymosin 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.
DRUGBlank control
Blank control
Sponsors
Beijing Anzhen Hospital
Second Affiliated Hospital of Nanchang University
Qilu Hospital of Shandong University
The First Affiliated Hospital of Guangzhou Medical University
Northern Jiangsu People's Hospital
Guangdong Provincial People's Hospital
First Affiliated Hospital of Kunming Medical University
Nanjing First Hospital, Nanjing Medical University
Shanghai East Hospital,Tongji University School of Medicine
The Seventh Affiliated Hospital of Xinjiang Medical University
TEDA International Cardiovascular Hospital
The First Affiliated Hospital of Bengbu Medical University
West China Hospital
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days after randomization | Death from any cause of 30 days after randomization |
Countries
China
Contacts
Primary ContactHong Liu, MD
Backup ContactHong-jia Zhang, MD
Outcome results
None listed