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

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• 作者：Fred A. Luchette ; M.D. ; M.Sc ; F.A.C.S.^a ; ^{fluchet@lumc.edu} ; Michael D. Pasquale ; M.D. ; F.A.C.S.^b ; Timothy C. Fabian ; M.D. ; F.A.C.S.^c ; Wayne K. Langholff ; Ph.D.^d ; Marsha Wolfson ; M.D. ; F A.C.P.^d
• 关键词：Anemia ; Epoetin alfa ; Orthopedic trauma ; Physical function outcome ; SF-36 ; LTTO
• 刊名：The American Journal of Surgery
• 出版年：2012
• 期刊代码：9_00029610
• 类别：med
• 出版时间：April, 2012
• 卷：203
• 期：4
• 页码：508-516
• 文件大小：582 K

摘要

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.