Study of Thymosin Alpha 1 to Prevent Immune Problems and Organ Damage After Surgery for Acute Aortic Dissection

What this Trial Is About

Systemic inflammatory response syndrome SIRS and multiple organ dysfunction syndrome MODS are major causes of death in patients with acute aortic syndrome AAS. Researchers are evaluating whether immunomodulatory therapy with thymosin alpha 1 during the acute phase of AAS can reduce the incidence of SIRS and MODS. This study is designed to test this hypothesis in patients undergoing emergency surgery for acute aortic syndrome. Participants will be randomly assigned to receive either thymosin alpha 1 or no additional treatment blank control. Thymosin alpha 1 is given as a 1.6 mg injection under the skin every 12 hours for 5 days during ICU admission. The treatment will stop if the patient is discharged from the ICU or dies. This randomized study uses triple masking to compare the effects of thymosin alpha 1 versus no treatment. During the study, researchers will monitor patients for 7 days after surgery, focusing on the highest Sequential Organ Failure Assessment SOFA score as the main outcome. They will also track 30-day mortality after randomization. Participants will be closely observed in the ICU while receiving treatment, and their organ function and immune response will be assessed. The study lasts through the critical postoperative period to evaluate safety and health outcomes related to thymosin alpha 1 administration.

Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)