Effect of thymosin α1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol.

This paper presents the protocol for PANDA II, a multicenter randomized controlled trial investigating whether thymosin alpha 1 (Tα1) supplementation can prevent organ dysfunction following acute type A aortic dissection (ATAAD) surgical repair. A total of 330 patients will be equally randomized to receive either Tα1 plus standard care or placebo plus standard care. The primary endpoint is the difference in mean postoperative Sequential Organ Failure Assessment (SOFA) scores measured daily through postoperative day 7. The scientific rationale centers on Tα1's proposed ability to rebalance post-operative immune dysregulation, thereby reducing systemic inflammatory response syndrome (SIRS)-mediated organ injury. As a protocol paper, no efficacy or outcome data are yet available. Limitations inherent to this stage include the absence of results, potential challenges in blinding given Tα1's immunological activity, and the complexity of standardizing post-surgical care across multiple centers. The trial is registered on ClinicalTrials.gov (NCT05339529). Findings will be published once the trial is completed, and this protocol represents a foundational step toward establishing evidence for Tα1 as a novel therapeutic strategy in this high-risk surgical population.

Why this grade: This is a published trial protocol only; no patient outcome data have been collected or reported yet, making it insufficient to grade evidence of efficacy in humans.