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

• Published in: The American journal of surgery 2012-04, Vol.203 (4), p.508-516
• Main Authors: Luchette, Fred A., M.D., M.Sc, F.A.C.S, Pasquale, Michael D., M.D., F.A.C.S, Fabian, Timothy C., M.D., F.A.C.S, Langholff, Wayne K., Ph.D, Wolfson, Marsha, M.D., F A.C.P
• Format: Article
• Language: English
• Subjects: Adult; Anemia; Anemia - diagnosis; Anemia - drug therapy; Anemias. Hemoglobinopathies; Biological and medical sciences; Blood; Blood transfusions; Cancer therapies; Chemotherapy; Chronic illnesses; Critical care; Critical Illness - mortality; Critical Illness - therapy; Diseases of red blood cells; Dose-Response Relationship, Drug; Double-Blind Method; Double-blind studies; Drug Administration Schedule; Drug dosages; Epoetin Alfa; Erythropoietin; Erythropoietin - administration & dosage; Female; Follow-Up Studies; General aspects; Hematologic and hematopoietic diseases; Hemoglobin; Hemoglobins - drug effects; Hospitals; Humans; Injections, Subcutaneous; Injuries; Injury Severity Score; Intensive care; Kidney diseases; Laboratories; LTTO; Male; Medical sciences; Mortality; Orthopedic trauma; Patients; Physical function outcome; Prospective Studies; Recombinant Proteins - administration & dosage; Reference Values; Rehabilitation; Risk Assessment; SF-36; Studies; Surgery; Survival Rate; Thromboembolism; Transfusion; Trauma; Treatment Outcome; Wounds and Injuries - diagnosis; Wounds and Injuries - drug therapy; Wounds and Injuries - surgery; Wounds, Nonpenetrating; Young Adult
• ISSN: 0002-9610; 1879-1883
• DOI: 10.1016/j.amjsurg.2011.08.006

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.