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Corwin HL, Gettinger A, Pearl RG, et al. Efficacy of Recombinant Human Erythropoietin in Critically Ill Patients: A Randomized Controlled Trial. JAMA. 2002;288(22):2827–2835. doi:10.1001/jama.288.22.2827
Author Affiliations: Critical Care Medicine (Dr H. Corwin) and Department of Anesthesiology (Dr Gettinger), Dartmouth-Hitchcock Medical Center, Lebanon, NH; Department of Anesthesia, Stanford University Medical Center, Stanford, Calif (Dr Pearl); Department of Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pa (Dr Fink); Rhode Island Hospital, Providence (Dr Levy); St Louis University Health Science Center, St Louis, Mo (Dr Shapiro); and Department of Pediatrics, Boston University School of Medicine (Dr M. Corwin), Department of Epidemiology, Boston University School of Public Health (Dr Colton), and CareStat Inc (Drs M. Corwin and Colton), Boston, Mass.
Context Anemia is common in critically ill patients and results in a large number
of red blood cell (RBC) transfusions. Recent data have raised the concern
that RBC transfusions may be associated with worse clinical outcomes in some
Objective To assess the efficacy in critically ill patients of a weekly dosing
schedule of recombinant human erythropoietin (rHuEPO) to decrease the occurrence
of RBC transfusion.
Design A prospective, randomized, double-blind, placebo-controlled, multicenter
trial conducted between December 1998 and June 2001.
Setting A medical, surgical, or a medical/surgical intensive care unit (ICU)
in each of 65 participating institutions in the United States.
Patients A total of 1302 patients who had been in the ICU for 2 days and were
expected to be in the ICU at least 2 more days and who met eligibility criteria
were enrolled in the study; 650 patients were randomized to rHuEPO and 652
Intervention Study drug (40 000 units of rHuEPO) or placebo was administered
by subcutaneous injection on ICU day 3 and continued weekly for patients who
remained in the hospital, for a total of 3 doses. Patients in the ICU on study
day 21 received a fourth dose.
Main Outcome Measures The primary efficacy end point was transfusion independence, assessed
by comparing the percentage of patients in each treatment group who received
any RBC transfusion between study days 1 and 28. Secondary efficacy end points
identified prospectively included cumulative RBC units transfused per patient
through study day 28; cumulative mortality through study day 28; change in
hemoglobin from baseline; and time to first transfusion or death.
Results Patients receiving rHuEPO were less likely to undergo transfusion (60.4%
placebo vs 50.5% rHuEPO; P<.001; odds ratio, 0.67;
95% confidence interval [CI], 0.54-0.83). There was a 19% reduction in the
total units of RBCs transfused in the rHuEPO group (1963 units for placebo
vs 1590 units for rHuEPO) and reduction in RBC units transfused per day alive
(ratio of transfusion rates, 0.81; 95% CI, 0.79-0.83; P = .04). Increase in hemoglobin from baseline to study end was greater
in the rHuEPO group (mean [SD], 1.32  g/dL vs 0.94 [1.9] g/dL; P<.001). Mortality (14% for rHuEPO and 15% for placebo) and adverse
clinical events were not significantly different.
Conclusions In critically ill patients, weekly administration of 40 000 units
of rHuEPO reduces allogeneic RBC transfusion and increases hemoglobin. Further
study is needed to determine whether this reduction in RBC transfusion results
in improved clinical outcomes.
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