The effect of anti-L-selectin (aselizumab) in multiple traumatized patients--results of a phase II clinical trial
| Autor: | M. Diefenbeck, Erwin Dhondt, Heinz Redl, Michael Beckert, Martijn van Griensven, Piotr Dziurdzik, Ulrich Schaechinger, Ansgar M. Brambrink, Jan Stroobants, Andreas Seekamp, Laura Wolowicka, Ingo Marzi, Jasmin Khan-Boluki, Jacek Gasiorowski, Stefan Rammelt, Norbert P. Haas, Ignace Demeyer, Guy Vundelinckx |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Oncology
Adult Male Resuscitation medicine.medical_specialty Adolescent medicine.drug_class Multiple Organ Failure Critical Care and Intensive Care Medicine Monoclonal antibody Double-Blind Method Intensive care Internal medicine Medicine Humans Prospective Studies L-Selectin Aged biology business.industry Multiple Trauma Incidence Antibodies Monoclonal Middle Aged Clinical trial Aselizumab Treatment Outcome Immunology Monoclonal biology.protein L-selectin Female Antibody business medicine.drug |
| Zdroj: | Critical care medicine. 32(10) |
| ISSN: | 0090-3493 |
| Popis: | 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 ofor =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 ofor =5 onor =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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|