Therapeutic Doses of Enoxaparin Sodium in Patients with High-Risk Acute Pancreatitis: A Randomized Study

Objective: To compare the efficacy and safety of therapeutic and standard prophylactic doses of enoxaparin sodium in adult patients with high-risk acute pancreatitis. Materials and methods: This prospective, randomized, open-label study with blinded outcome assessment included a 28-day follow-up period. Inclusion criteria: adult patients hospitalized within 24 hours of symptom onset. High risk was defined using a logistic model incorporating the BISAP (Bedside Index for Severity in Acute Pancreatitis) score, interleukin-6 level at 24 hours, change in interleukin-22 (48–24 h), and thromboelastography K-time. • Treatment group: enoxaparin sodium 1 mg/kg subcutaneously every 12 hours for 7 days or until hospital discharge. • Control group: enoxaparin sodium 40 mg once daily. Primary endpoint: a 28-day composite outcome including death, persistent organ failure lasting (>48 h), or infected pancreatic necrosis, according to the 2012 revised Atlanta Classification. Results: A total of 141 patients were analyzed (70 and 71 patients). The composite outcome occurred less frequently in the therapeutic-dose low-molecular-weight heparin group than in the control group (37.1% vs 54.9%; p = 0.035). Mortality (7.1% vs 15.5%; p = 0.11) and the incidence of pancreatic necrosis (14.2% vs 26.7%; p = 0.07) were also lower, although the differences did not reach statistical significance. The groups were comparable in terms of the incidence of bleeding (1.4% vs 0; p = 1.00). Conclusion: In patients with high-risk acute pancreatitis, early administration of therapeutic-dose enoxaparin sodium reduced the incidence of a severe 28-day composite outcome without an apparent increase in the risk of bleeding, supporting a personalized approach to low-molecular-weight heparin therapy in this patient population.