Status
Recruiting
Phase
Not applicable
Enrollment
330
Locations
15
Results
Not posted
Publications
1
Study 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
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.
DRUG
Blank control
Timeline
First posted
Apr 21, 2022
Study start
Jul 1, 2022
Primary completion
Dec 31, 2025
Study completion
Dec 31, 2025
Results posted
Not reported
Registry updated
Dec 12, 2024
Outcomes
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.
30-day mortality
Time frame · 30 days after randomization
Death from any cause of 30 days after randomization
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital Nanjing Medical University
Nanjing, Jiangsu, China
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The Friendship Hospital of Yili Kazak Autonomous Prefecture
Kazak, Xinjiang, China
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Beijing Anzhen Hospital Capital Medical University
Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Shanghai East Hospital Tongji University
Shanghai, China
TEDA International Cardiovascular Hospital
Tianjin, China
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