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

Andreas Seekamp, Martijn Van Griensven, Erwin Dhondt, Michael Diefenbeck, Ignace Demeyer, Guy Vundelinckx, Norbert Haas, Ulrich Schaechinger, Laura Wolowicka, Stefan Rammelt, Jan Stroobants, Ingo Marzi, Ansgar Brambrink, Piotr Dziurdzik, Jacek Ga̧siorowski, Heinz Redl, Michael Beckert, Jasmin Khan-Boluki

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Objective: The objectives of this study were to evaluate safety (primary) and clinical efficacy (secondary) of the humanized monoclonal anti-L-seiectin 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 ≥25. 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 dependency 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 ≥5 on ≥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 hospitalisation 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.

Original languageEnglish (US)
Pages (from-to)2021-2028
Number of pages8
JournalCritical Care Medicine
Volume32
Issue number10
DOIs
StatePublished - Oct 2004
Externally publishedYes

Fingerprint

L-Selectin
Phase II Clinical Trials
Placebos
Multiple Organ Failure
Trauma Centers
Leukopenia
Intensive Care Units
Organ Dysfunction Scores
Injury Severity Score
Belgium
Wounds and Injuries
Poland
Infection
Artificial Respiration
Germany
Length of Stay
Hospitalization
Randomized Controlled Trials
Safety
Antibodies

Keywords

  • Clinical trial
  • Intensive care
  • L-selectin antibody
  • Multiple trauma
  • Neutrophil adhesion
  • Organ failure

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Seekamp, A., Van Griensven, M., Dhondt, E., Diefenbeck, M., Demeyer, I., Vundelinckx, G., ... Khan-Boluki, J. (2004). The effect of anti-L-selectin (aselizumab) in multiple traumatized patients - Results of a phase II clinical trial. Critical Care Medicine, 32(10), 2021-2028. https://doi.org/10.1097/01.CCM.0000142396.59236.F3

The effect of anti-L-selectin (aselizumab) in multiple traumatized patients - Results of a phase II clinical trial. / Seekamp, Andreas; Van Griensven, Martijn; Dhondt, Erwin; Diefenbeck, Michael; Demeyer, Ignace; Vundelinckx, Guy; Haas, Norbert; Schaechinger, Ulrich; Wolowicka, Laura; Rammelt, Stefan; Stroobants, Jan; Marzi, Ingo; Brambrink, Ansgar; Dziurdzik, Piotr; Ga̧siorowski, Jacek; Redl, Heinz; Beckert, Michael; Khan-Boluki, Jasmin.

In: Critical Care Medicine, Vol. 32, No. 10, 10.2004, p. 2021-2028.

Research output: Contribution to journalArticle

Seekamp, A, Van Griensven, M, Dhondt, E, Diefenbeck, M, Demeyer, I, Vundelinckx, G, Haas, N, Schaechinger, U, Wolowicka, L, Rammelt, S, Stroobants, J, Marzi, I, Brambrink, A, Dziurdzik, P, Ga̧siorowski, J, Redl, H, Beckert, M & Khan-Boluki, J 2004, 'The effect of anti-L-selectin (aselizumab) in multiple traumatized patients - Results of a phase II clinical trial', Critical Care Medicine, vol. 32, no. 10, pp. 2021-2028. https://doi.org/10.1097/01.CCM.0000142396.59236.F3
Seekamp, Andreas ; Van Griensven, Martijn ; Dhondt, Erwin ; Diefenbeck, Michael ; Demeyer, Ignace ; Vundelinckx, Guy ; Haas, Norbert ; Schaechinger, Ulrich ; Wolowicka, Laura ; Rammelt, Stefan ; Stroobants, Jan ; Marzi, Ingo ; Brambrink, Ansgar ; Dziurdzik, Piotr ; Ga̧siorowski, Jacek ; Redl, Heinz ; Beckert, Michael ; Khan-Boluki, Jasmin. / The effect of anti-L-selectin (aselizumab) in multiple traumatized patients - Results of a phase II clinical trial. In: Critical Care Medicine. 2004 ; Vol. 32, No. 10. pp. 2021-2028.
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AU - Diefenbeck, Michael

AU - Demeyer, Ignace

AU - Vundelinckx, Guy

AU - Haas, Norbert

AU - Schaechinger, Ulrich

AU - Wolowicka, Laura

AU - Rammelt, Stefan

AU - Stroobants, Jan

AU - Marzi, Ingo

AU - Brambrink, Ansgar

AU - Dziurdzik, Piotr

AU - Ga̧siorowski, Jacek

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N2 - Objective: The objectives of this study were to evaluate safety (primary) and clinical efficacy (secondary) of the humanized monoclonal anti-L-seiectin 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 ≥25. 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 dependency 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 ≥5 on ≥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 hospitalisation 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.

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KW - Multiple trauma

KW - Neutrophil adhesion

KW - Organ failure

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