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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Aortic Syndrome, Aortic Dissectio

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymosin alpha 1<br>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-<br>* 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.<br>|
| Sham Comparator: Blank control<br> | Drug: Blank control<br>* Blank control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Death from any cause of 30 days after randomization | 30 days after randomization |