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Intensive care medicine · Mar 2003
Comment Randomized Controlled Trial Multicenter Study Clinical TrialDCL-Hb for trauma patients with severe hemorrhagic shock: the European "On-Scene" multicenter study.
- Thoralf Kerner, Olaf Ahlers, Siegfried Veit, Bruno Riou, Michael Saunders, Ulrich Pison, and European DCLHb Trauma Study Group.
- Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Virchow-Klinikum, Charité, Humboldt Universität, Augustenburger Platz 1, 13353 Berlin, Germany.
- Intensive Care Med. 2003 Mar 1; 29 (3): 378-85.
ObjectiveA major cause of death in patients with severe hemorrhagic shock following trauma is the subsequent occurrence of multiple organ failure due to tissue hypoxia. Early administration of an oxygen carrier may reduce the occurrence of organ failures and improve survival. It may also reduce the need of blood products.Design And SettingProspective multicenter study in a university clinic.Patients121 patients with severe hemorrhagic shock.InterventionsPatients were randomly assigned "on-scene" to receive either up to 1000 ml of a 10% diaspirin cross-linked hemoglobin (DCLHb) solution or the study center's standard therapy.Measurements And ResultsDemographic and physiological characteristics of the two treatment groups at baseline were comparable. Organ failures and survival rates until day 5 and day 28 showed no significant differences. The sponsor therefore terminated this trial prematurely after an interim evaluation of the data indicated no evidence of efficacy to offset concerns raised about the safety of DCLHb. Median volumes of cumulative blood products administered on 1 (1595 vs. 3716 ml) and 7 days (3139 vs. 4746 ml) after admission were lower in the DCLHb group.ConclusionsThe early application of an oxygen carrier (DCLHb) to patients with severe hemorrhagic shock following trauma had no significant effect on the occurrence of organ failure or on 5- and 28-day survival in this abbreviated trial. However, early infusion of up to 1000 ml DCLHb reduces the need for blood products without changing morbidity or survival.
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