The Effect of Anti-L-Selectin (Aselizumab) on the Posttraumatic Inflammatory Response in Multiply Traumatized Patients |
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Authors: | Andreas Seekamp Martijn van Griensven Christian Rusu Jochem K?nig Jasmin Khan-Boluki Heinz Redl |
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Affiliation: | (1) Department of Traumatology, Saarland University Medical School, Homburg/Saar, Germany;(2) Department of Traumatology, Hanover Medical School, Hanover, Germany;(3) Department of Medical Statistics, Epidemiology and Medical Informatics, Saarland University Medical School, Homburg/Saar, Germany;(4) Scil Biomedicals GmbH, Martinsried, Germany;(5) Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria;(6) Klinik für Unfallchirurgie, Universit?tsklinikum Schleswig-Holstein, Campus Kiel, Arnold-Heller-Stra?e 7, 24105 Kiel, Germany |
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Abstract: | Abstract 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. |
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Keywords: | Multiple trauma Organ failure L-selectin Neutrophil adhesion Inflammation Clinical trial |
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