The effect of anti-L-selectin (aselizumab) in multiple traumatized patients--results of a phase II clinical trial

• Published in: Critical care medicine Vol. 32; no. 10; p. 2021
• Main Authors: Seekamp, Andreas, van Griensven, Martijn, Dhondt, Erwin, Diefenbeck, Michael, Demeyer, Ignace, Vundelinckx, Guy, Haas, Norbert, Schaechinger, Ulrich, Wolowicka, Laura, Rammelt, Stefan, Stroobants, Jan, Marzi, Ingo, Brambrink, Ansgar M, Dziurdzik, Piotr, Gasiorowski, Jacek, Redl, Heinz, Beckert, Michael, Khan-Boluki, Jasmin
• Format: Journal Article
• Language: English
• Published: United States 01.10.2004
• Subjects: Adolescent; Adult; Aged; Antibodies, Monoclonal - immunology; Antibodies, Monoclonal - therapeutic use; Double-Blind Method; Female; Humans; Incidence; L-Selectin - immunology; Male; Middle Aged; Multiple Organ Failure - epidemiology; Multiple Organ Failure - immunology; Multiple Organ Failure - prevention & control; Multiple Trauma - complications; Multiple Trauma - immunology; Prospective Studies; Treatment Outcome
• ISSN: 0090-3493
• DOI: 10.1097/01.ccm.0000142396.59236.f3

The objectives of this study were to evaluate safety (primary) and clinical efficacy (secondary) of the humanized monoclonal anti-L-selectin antibody aselizumab in severely injured patients. Prospective phase II, parallel group, double-blind, randomized, placebo-controlled clinical trial. Fourteen medical intensive care units or trauma units in level I trauma centers in Belgium, Germany, and Poland. Eighty-four patients with a sustained trauma due to a blunt or penetrating injury and a total Injury Severity Scale score of > or =25. Patients received either aselizumab at dosages of 0.5, 1, or 2 mg/kg or placebo within 6 hrs of the traumatic event and were followed for 6 wks. The number of expeditable adverse events increased dose dependently over the aselizumab groups compared with placebo. There were no statistically significant differences between all groups regarding leukopenia and risk of infection. No immunologic response following infusion of aselizumab was noted. The number of patients with multiple organ failure, defined as a median value of the total Goris Multiple Organ Failure score of > or =5 on > or =2 consecutive days within 14 days, was not significantly different for the 0.5 mg/kg, 1 mg/kg, 2 mg/kg, and placebo groups. There were no statistically significant differences in time of mechanical ventilation, length of stay in an intensive care unit, and total duration of hospitalization between treatment groups. Aselizumab was associated with a higher rate of infections and leucopenia; however, this difference was not significantly different compared with placebo. For all efficacy variables, aselizumab presented no significant trends but only a few scattered statistically significant differences between groups.