The effect of anti-L-selectin (Aselizumab) on the posttraumatic inflammatory response in multiply traumatized patients

Purpose: This prospective phase II parallel-group, double-blind, randomized, placebo-controlled clinical trial was meant to evaluate the effect of a humanized monoclonal anti-L-selectin antibody (aselizumab) on the posttraumatic inflammatory response in severely injured patients. Patients and Methods: To be eligible for the study, patients had to have sustained a trauma due to a blunt or penetrating injury, which involved at least two organ systems according to the Abbreviated Injury Scale (AIS) resulting in a total Injury Severity Score (ISS) of ≥ 25. Included patients (n = 84) received either placebo or 0.5 mg/kg, 1.0 mg/kg, or 2.0 mg/kg of aselizumab within 6 h of the traumatic event. Parameters representing the posttraumatic inflammatory response were monitored for 10 days, patients' general records were monitored for 14 days and discontinuously until day 42. Results: The incidence of multiple organ failure (MOF) defined as a median value of the total Goris MOF score of ≥ 5 on ≥ 2 consecutive days within the first 14 days was not significantly different for the placebo and the 0.5-mg/kg, 1.0-mg/kg, and 2.0-mg/kg groups. The cytokine interleukin-(IL-)6 and IL-10 serum levels as well as neutrophil elastase serum concentrations revealed the well-described posttraumatic acute response which resolved from day 3 after trauma in all four study groups. Also complement factor C3a and procalcitonin followed the same pattern. There were no statistically significant differences between placebo and patients having received anti-L-selectin at different dosages. Conclusion: For all of the measured variables, IL-6, IL-10, elastase, C3a and procalcitonin, there were only a few trends but no significant differences between all study groups indicating that the effect of the administered anti-L-selectin antibody on the posttraumatic inflammatory response was similar to that of placebo.