A randomized, double-blind, placebo-controlled study to assess the effect of recombinant human erythropoietin on functional outcomes in anemic, critically ill, trauma subjects: the Long Term Trauma Outcomes Study. Journal Article


Authors: Luchette, F. A.; Pasquale, M. D.; Fabian, T. C.; Langholff, W. K.; Wolfson, M.
Article Title: A randomized, double-blind, placebo-controlled study to assess the effect of recombinant human erythropoietin on functional outcomes in anemic, critically ill, trauma subjects: the Long Term Trauma Outcomes Study.
Abstract: BACKGROUND: Achieving a higher hemoglobin (Hb) level might allow the anemic, critically ill, trauma patient to have an improved outcome during rehabilitation therapy. METHODS: Patients with major blunt trauma orthopedic injuries were administered epoetin alfa or placebo weekly both in hospital and for up to 12 weeks after discharge or until the Hb level was >12.0 g/dL, whichever occurred first. The 36-question Short Form Health Assessment questionnaire (SF-36) was used to evaluate physical function (PF) outcomes at baseline, at hospital discharge, and at several time points posthospital discharge. RESULTS: One hundred ninety-two patients were enrolled (epoetin alfa [n = 97], placebo [n = 95]). Hb increased from baseline to hospital discharge in both groups (epoetin alfa: 1.2 g/dL vs placebo: 0.9 g/dL), and transfusion requirements were similar between groups. Both groups showed improvements in SF-36 PF; there were no significant differences in the average of all posthospital discharge scores (epoetin alfa: 27.3 vs placebo 30.9; P = 0.38). Thromboembolic events were similar between groups. CONCLUSIONS: No differences were observed in physical function outcomes or safety in anemic, critically ill, trauma patients treated with epoetin alfa compared with placebo. Copyright Copyright 2012 Elsevier Inc. All rights reserved.
Journal Title: American Journal of Surgery
Volume: 203
Issue: 4
ISSN: 1879-1883; 0002-9610
Publisher: Elsevier Inc  
Journal Place: United States
Date Published: 2012
Start Page: 508
End Page: 516
Language: English
DOI/URL:
Notes: ID: 12316; Record Owner: From MEDLINE, a database of the U.S. National Library of Medicine.; Status: MEDLINE; Publishing Model: Journal available in: Print-Electronic Citation processed from: Internet; NLM Journal Code: 3z4, 0370473; CAS Registry/EC Number/Name of Substance: 0 (Hemoglobins). 0 (Recombinant Proteins). 11096-26-7 (Erythropoietin). 113427-24-0 (epoetin alfa).; Electronic Date of Publication: 20111215; Entry Date: 20120509