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

Sponsor

Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05339529

Collaborator

Beijing Anzhen Hospital (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Aortic Syndrome Aortic Dissectio	Drug: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- Drug: Blank control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thymosin alpha 1 1.6 mg q12h for 5 days	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.
Sham Comparator: Blank control	Drug: Blank control Blank control

Arm

Intervention/Treatment

Experimental: Thymosin alpha 1

1.6 mg q12h for 5 days

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.

Sham Comparator: Blank control

Drug: Blank control

Blank control

Outcome Measures

Primary Outcome Measures

The highest Sequential Organ Failure Assessment (SOFA) score of 14 days after surgery [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.

Secondary Outcome Measures

30-day mortality [30 days after randomization]
Death from any cause of 30 days after randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu	China	210029
2	Beijing Anzhen Hospital	Beijing		China	10029

Sponsors and Collaborators

Nanjing Medical University
Beijing Anzhen Hospital

Investigators

Principal Investigator: Hong Liu, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hong Liu, Principal Investigator of Cardiovascular Surgery, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05339529

Other Study ID Numbers:

5A-Plan V

First Posted:

Apr 21, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Syndrome

Glycine

Thymalfasin

Study Results

No Results Posted as of Aug 2, 2022