Thymosin Alpha 1 trial to test prevention of infected pancreatic necrosis in acute necrotising pancreatitis patients

In patients with acute necrotising pancreatitis (ANP), the most significant causes of mortality are infected pancreatic necrosis (IPN) and its associated septic complications. Preventing the secondary infection of necrotic pancreatic tissue is therefore a primary clinical goal with immense value for improving patient outcomes. Current management strategies often focus on supportive care and intervention after infection has already occurred. This trial explores a novel preventive approach using immunomodulatory therapy. Thymosin alpha 1 is hypothesized to be beneficial due to its effects on the immune system, potentially bolstering the patient's ability to resist secondary infections during the vulnerable acute phase of ANP. The TRACE trial was specifically designed to evaluate this immune-focused therapy as a new strategy for preventing IPN.

This is a protocol for a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial named the TRACE trial. A total of 520 eligible adult patients with acute necrotising pancreatitis (ANP) will be enrolled and randomised in a 1:1 ratio. One group will receive thymosin alpha 1, while the control group will receive a matching placebo via the same route of administration. The primary endpoint is the incidence of infected pancreatic necrosis (IPN) during the initial hospital admission. The study will also measure human leucocyte antigens-DR (HLA-DR) on days 0, 7, and 14.

This is a trial protocol, so it does not contain any results or findings. The study is designed to test a primary hypothesis: that administering thymosin alpha 1 during the acute phase of ANP will lead to a statistically significant reduction in the incidence of IPN. Secondary outcomes to be measured include a wide range of clinical events. During the index hospital admission, the trial will track in-hospital mortality, new-onset single or persistent organ failure (respiratory, cardiovascular, renal), the need for new organ support therapies like ventilation or dialysis, and the requirement for procedural interventions such as drainage or necrosectomy. It will also record bleeding events that require intervention and any adverse events related to the treatment. To capture longer-term outcomes, a follow-up assessment is scheduled 90 days after enrolment to register instances of IPN and death that may occur after the initial hospital discharge.