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

Nanjing Medical University

Status: Invitation-only

Conditions: Aortic Dissection Aneurysm; Aortic Dissection

Treatments: Drug: Ulinastatin only; Drug: Ulinastatin and Thymosin α1

Study type: Interventional

Funder types: Other

Identifiers

NCT06966687

PANDA XI

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

UT Group

Experimental group

Description:

Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery

Treatment:

Drug: Ulinastatin and Thymosin α1

Control Group

Active Comparator group

Description:

Ulinastatin (100000U TID for 5 days) immediately after surgery

Treatment:

Drug: Ulinastatin only