Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Thymosin α1) V

Acute Aortic Syndrome Clinical Trial

Official title:

Effects of Thymosin α1 on Inflammatory Response for Acute Aortic Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339529
• Other study ID #: 5A-Plan V
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Nanjing Medical University
• Contact: Hong Liu
• Phone: 18801281613
• Email: DR.HONGLIU[@]FOXMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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 a1;
• 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.

Related Conditions & MeSH terms

• Acute Aortic Syndrome
• Syndrome

Intervention

Drug:
• Thymosin 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.
• Blank control
Blank control

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Nanjing Medical University	Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The highest Sequential Organ Failure Assessment (SOFA) score of 14 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.	14 days after surgery
Secondary	30-day mortality	Death from any cause of 30 days after randomization	30 days after randomization