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

N/AEnrolling By InvitationNCT06966687

Nanjing Medical University200 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 in addition to antiinflammatory treatment may be beneficial. This study was designed to test the hypothesis that the administration of Ulinastatin and Thymosin α1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Aortic Dissection Aortic Dissection Aneurysm

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 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 or Ulinastatin; * 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 (4)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Shanghai East Hospital Tongji University

Shanghai, Shanghai Municipality, China

West China Hospital

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

The mean Sequential Organ Failure Assessment (SOFA) score of 7 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.

Time frame: within the prior 7 days after surgery.