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


METHODS
Prospective phase II, parallel group, double-blind, randomized, placebo-controlled clinical trial.


METHODS
Fourteen medical intensive care units or trauma units in level I trauma centers in Belgium, Germany, and Poland.


METHODS
Eighty-four patients with a sustained trauma due to a blunt or penetrating injury and a total Injury Severity Scale score of > or =25.


METHODS
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.


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 > 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.


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.
Department of Traumatology, Saarland University Hospital, Homburg, FRG. chasee@uniklinik-saaarland.de
Andreas
A
Seekamp
Martijn
M
van Griensven
Erwin
E
Dhondt
Michael
M
Diefenbeck
Ignace
I
Demeyer
Guy
G
Vundelinckx
Norbert
N
Haas
Ulrich
U
Schaechinger
Laura
L
Wolowicka
Stefan
S
Rammelt
Jan
J
Stroobants
Ingo
I
Marzi
Ansgar M
AM
Brambrink
Piotr
P
Dziurdzik
Jacek
J
Gasiorowski
Heinz
H
Redl
Michael
M
Beckert
Jasmin
J
Khan-Boluki
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000276:immunology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D019041:L-Selectin / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control; D009104:Multiple Trauma / Q000150:complications / Q000276:immunology*; D011446:Prospective Studies; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D019041:L-Selectin