
Item type: | Article | ||||
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Journal or Publication Title: | Critical Care Medicine | ||||
Publisher: | LIPPINCOTT WILLIAMS & WILKINS | ||||
Place of Publication: | PHILADELPHIA | ||||
Volume: | 32 | ||||
Number of Issue or Book Chapter: | 10 | ||||
Page Range: | pp. 2021-2028 | ||||
Date: | 2004 | ||||
Institutions: | Medicine > Lehrstuhl für Unfallchirurgie | ||||
Identification Number: |
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Keywords: | LEUKOCYTE ADHESION MOLECULE-1; SOLUBLE L-SELECTIN; ORGAN FAILURE; SURFACE EXPRESSION; LUNG INJURY; NEUTROPHIL; MIGRATION; SEPSIS; ISCHEMIA/REPERFUSION; TRANSMIGRATION; multiple trauma; organ failure; neutrophil adhesion; L-selectin antibody; clinical trial; intensive care | ||||
Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||
Status: | Published | ||||
Refereed: | Yes, this version has been refereed | ||||
Created at the University of Regensburg: | Yes | ||||
Item ID: | 71262 |
Abstract
Objective: 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. Design: Prospective phase II, parallel group, double-blind, randomized, placebo-controlled clinical trial. Setting: Fourteen medical intensive care units or trauma units in level I trauma centers ...

Abstract
Objective: 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. Design: Prospective phase II, parallel group, double-blind, randomized, placebo-controlled clinical trial. Setting: Fourteen medical intensive care units or trauma units in level I trauma centers in Belgium, Germany, and Poland. Patients: Eighty-four patients with a sustained trauma due to a blunt or penetrating injury and a total Injury Severity Scale score of greater than or equal to25. Interventions: 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. Measurements and Main Results: 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 greater than or equal to5 on greater than or equal to2 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. Conclusions. 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.
Metadata last modified: 19 Dec 2024 15:11