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DCL-Hb for trauma patients with severe hemorrhagic shock: the European "On-Scene" Multicenter Study

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Abstract

Objective

A 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 setting

Prospective multicenter study in a university clinic.

Patients

121 patients with severe hemorrhagic shock.

Interventions

Patients 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 results

Demographic 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.

Conclusions

The 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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Acknowledgements

We are indebted to the study coordinators, treating health personnel, clinical research and laboratory associates who participated in this trial, and to U. Frei, K. J. Falke, and N. Haas for their support. Baxter Healthcare Corporation funded this study.

Author information

Authors and Affiliations

  1. Klinik für Anästhesiologie und Operative Intensivmedizin,Campus Virchow-Klinikum, Charité , Humboldt Universität, Augustenburger Platz 1, 13353, Berlin, Germany

    Thoralf Kerner, Olaf Ahlers & Ulrich Pison

  2. Anästhesiologie und Intensivtherapie, Krankenhaus im Friedrichshain, Berlin, Germany

    Siegfried Veit

  3. Service d'Accueil des Urgences et Département, d'Anesthésie-Réanimation, Groupe hospitalier Pitié-Salpêtrière,Assistance Publique-Hôpitaux de Paris , Université Pierre et Marie Curie, Paris, France

    Bruno Riou

  4. Hemoglobin Therapeutics, Baxter Healthcare Corporation, Boulder, Colo., USA

    Michael Saunders

Authors
  1. Thoralf Kerner
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  2. Olaf Ahlers
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  3. Siegfried Veit
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  4. Bruno Riou
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  5. Michael Saunders
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  6. Ulrich Pison
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Consortia

for the European DCLHb Trauma Study Group

Corresponding author

Correspondence to Ulrich Pison.

Additional information

This research was supported by Baxter Healthcare Corporation, Boulder, Colo., USA. The members of the European DCLHb Trauma Study Group are listed in the Appendix.

An editorial regarding this article can be found in the same issue (http://dx.doi.org/10.1007/s00134-003-1637-y)

Appendix: further members of the European DCLHb Trauma Study Group

Appendix: further members of the European DCLHb Trauma Study Group

P. Todorov (CIU Hôpital Ambroise Parè, Mons, Belgium); C. De Deyne (Sint Jansziekenhuis, Genk, Belgium); P. Mols (Centre Hospitalier Universitaire St. Pierre, Brussels, Belgium); A. Fox (Centre Hospitalier Regional de Namur, Belgium); K. Samii (Centre Hospitalier Bicètre, Le Kremlin Bicêtre, France); M. Ossart (Centre Hospitalier Universitaire Amiens Nord, France); P. Dabadie (Centre Hospitalier Universitaire Pellegrin, Bordeaux, France); J. Bertrand (Centre Hospitalier Universitaire St. Etienne, Saint-Etienne, France); P. Coriat (Groupe Hospitalier Pitié-Salpêtrière, Paris, France); D. Guerrini (Hôpital A. Mignot, Le Chesnay, France); J. Marty (Hôpital Beaujon, Clichy, France); J. Desmonts (Hôpital Bichat, Paris, France); J. Poussel (Hôpital Bon-Secours, Metz, France); D. Payen (Hôpital Lariboisiere, Paris, France); B. Rouvier (Hôpital Percy, Clamart, France); P. Adnet (Hôpital R. Salengro, Lille, France); P. Feiss (Hôpital Universitaire Dupuytren, Limoges, France); W. Dick (Universität Mainz, Germany); K. Ellinger (Klinikum Mannheim, Germany); G. Regel (Medizinische Hochschule Hannover, Germany); P. Schmucker (Medizinische Uni Lübeck, Germany); J. Motsch (Universität Heidelberg, Germany); K. Unertl (Universität Tübingen, Germany); G. Benad (Universität Rostock, Germany); G. Hempelmann (Universität Giessen, Germany). Data Monitoring Committee: J. Bion, P. Ferdinande, A. Grootendorst, R. Little, C. Robertson, D. Spahn, D. Spiegelhalter, A. Webb; Statistical Data Analysis Center (Quintiles): A. Huriez, P. Buse, E. Rump, D. Green, V. Murray, J. McDermott, P. Larcier. Triskel Integrated Services: J. Le Cotonnec, F. Steinhauslin, D. Cuquoz; Baxter Healthcare Corporation: S. Holmstrom, D. Gerard, T. Reppucci, A. Morrison (at Nivelles, Belgium); J. Blue, C. Goldberg, R. Przybelski, K. Stern, J. Houghton, R. Sperelakis, K. Wallace, J. Petty, D. Balma, B. Bottoms (at Round Lake, Ill., USA); P. Carli (SAMU 75 and Centre Hospitalo-Universitaire Necker-Enfants Malades, Paris).

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Kerner, T., Ahlers, O., Veit, S. et al. DCL-Hb for trauma patients with severe hemorrhagic shock: the European "On-Scene" Multicenter Study. Intensive Care Med 29, 378–385 (2003). https://doi.org/10.1007/s00134-002-1622-x

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  • DOI: https://doi.org/10.1007/s00134-002-1622-x

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