DCL-Hb for trauma patients with severe hemorrhagic shock: the European "On-Scene" multicenter study.
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.


METHODS
Prospective multicenter study in a university clinic.


METHODS
121 patients with severe hemorrhagic shock.


METHODS
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.


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.
Kerner
Thoralf
T
Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Virchow-Klinikum, Charité, Humboldt Universität, Augustenburger Platz 1, 13353 Berlin, Germany.
Ahlers
Olaf
O
Veit
Siegfried
S
Riou
Bruno
B
Saunders
Michael
M
Pison
Ulrich
U
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D001802:Blood Substitutes / Q000627:therapeutic use*; D005062:European Union; D005260:Female; D005440:Fluid Therapy; D006454:Hemoglobins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D012771:Shock, Hemorrhagic / Q000150:complications / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D015996:Survival Rate; D015599:Trauma Severity Indices; D016896:Treatment Outcome
D001802:Blood Substitutes; D006454:Hemoglobins; C083478:diaspirin-cross-linked hemoglobin; D001241:Aspirin