Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)

Nanjing Medical University600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

600

Conditions

Acute Aortic Syndrome Aortic Dissection Type A

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (15)

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

...and 5 more locations

Outcomes

Primary Outcomes

7-day postoperative organ dysfunction burden assessed by mean daily SOFA score

The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys

Time frame: 7 days after surgery

Secondary Outcomes

30-day mortality

Death from any cause of 30 days after randomization

Time frame: 30 days after randomization