Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: A randomized, prospective, placebo-controlled clinical trial

Tzu Hsien Tsai, Cheng Hsien Lu, Christopher Glenn Wallace, Wen Neng Chang, Shu Feng Chen, Chi Ren Huang, Nai Wen Tsai, Min Yu Lan, Pei Hsun Sung, Chu Feng Liu, Hon Kan Yip*

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

48 Scopus citations

Abstract

Introduction: Mortality and disability following ischemic stroke (IS) remains unacceptably high with respect to the conventional therapies. This study tested the effect of erythropoietin (EPO) on long-term neurological outcome in patients after acute IS. This study aimed to evaluate the safety and efficacy of two consecutive doses of EPO (5,000 IU/dose, subcutaneously administered at 48 hours and 72 hours after acute IS) on improving the 90-day combined endpoint of recurrent stroke or death that has been previously reported. A secondary objective was to evaluate the long-term (that is, five years) outcome of patients who received EPO. Methods: This was a prospective, randomized, placebo-controlled trial that was conducted between October 2008 and March 2010 in a tertiary referral center. IS stroke patients who were eligible for EPO therapy were enrolled into the study. Results: The results showed that long-term recurrent stroke and mortality did not differ between group 1 (placebo-control; n = 71) and group 2 (EPO-treated; n = 71). Long-term Barthel index of <35 (defining a severe neurological deficit) was lower in group 2 than group 1 (P = 0.007). Multiple-stepwise logistic-regression analysis showed that EPO therapy was significantly and independently predictive of freedom from a Barthel index of <35 (P = 0.029). Long-term major adverse neurological event (MANE; defined as: death, recurrent stroke, or long-term Barthel index < 35) was lower in group 2 than group 1 (P = 0.04). Log-Rank test showed that MANE-free rate was higher in group 2 than group 1 (P = 0.031). Multiple-stepwise Cox-regression analysis showed that EPO therapy and higher Barthel Index at day 90 were independently predictive of freedom from long-term MANE (all P <0.04). Conclusion: EPO therapy significantly improved long-term neurological outcomes in patients after IS. Trial registration: ISRCTN71371114. Registered 10 October 2008.

Original languageEnglish
Article number49
JournalCritical Care
Volume19
Issue number1
DOIs
StatePublished - 25 02 2015
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2015 Tsai et al.

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