Seekamp, Andreas and van Griensven, Martijn and Dhont, Erwin and Diefenbeck, Michael and Demeyer, Ignace and Vundelinckx, Guy and Haas, Norbert and Schaechinger, Ulrich and Wolowickwa, Laura and Rammelt, Stefan and Stroobants, Jan and Marzi, Ingo and Brambrink, Ansgar M. and Dziurdzik, Piotr and Gasiorowki, Jacek and Redl, Heinz and Beckert, Michael and Khan-Boluki, Jasmin (2004) The effect of anti-L-selectin (aselizumab) in multiple traumatized patients - Results of a phase II clinical trial. CRITICAL CARE MEDICINE, 32 (10). pp. 2021-2028. ISSN 0090-3493, 1530-0293
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled 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 |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Unfallchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 28 Jun 2021 06:48 |
| Last Modified: | 28 Jun 2021 06:48 |
| URI: | https://pred.uni-regensburg.de/id/eprint/37105 |
Actions (login required)
 |
View Item |
