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

Primary Purpose

Acute Aortic Syndrome, Aortic Dissectio

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
Blank control
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Aortic Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The first affiliated hospital of nanjing medical universityRecruiting
  • Beijing Anzhen HospitalRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Thymosin alpha 1

Blank control

Arm Description

1.6 mg q12h for 5 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2022
Last Updated
September 25, 2022
Sponsor
Nanjing Medical University
Collaborators
Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT05339529
Brief Title
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Thymosin α1) V
Official Title
Effects of Thymosin α1 on Inflammatory Response for Acute Aortic Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Aortic Syndrome, Aortic Dissectio

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymosin alpha 1
Arm Type
Experimental
Arm Description
1.6 mg q12h for 5 days
Arm Title
Blank control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Blank control
Intervention Description
Blank control
Primary Outcome Measure Information:
Title
The highest Sequential Organ Failure Assessment (SOFA) score of 14 days after surgery
Description
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.
Time Frame
14 days after surgery
Secondary Outcome Measure Information:
Title
30-day mortality
Description
Death from any cause of 30 days after randomization
Time Frame
30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu
Phone
18801281613
Email
DR.HONGLIU@FOXMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Zhao
Phone
02568303105
Email
zhaosheng0824@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Liu
Organizational Affiliation
Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of nanjing medical university
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD
Phone
188012181613
Email
dr.hongliu@foxmail.com
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD
Phone
18801281613
Email
DR.HONGLIU@FOXMAIL.COM
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
10029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai-yang LI
Email
ocean0203@163.com
First Name & Middle Initial & Last Name & Degree
Si-chong Qian, MD
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-hua Zeng, MD
First Name & Middle Initial & Last Name & Degree
Zhi-hua Zeng, MD
Email
284569849@QQ.COM
First Name & Middle Initial & Last Name & Degree
Zhi-hua Zeng, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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