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临床试验/IRCT2014122920471N1
IRCT2014122920471N1已完成2 期

Effects of Human Recombinant Erythropoietine on Functional Outcome of Traumatic Cervical Spine Cord Injury; A Randomized Placebo Controlled Study

Shiraz University of Medical Science0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20

研究概览

简要总结

Objective: To determine the effects of recombinant human erythropoietin (rhEPO) on functional outcome and disability of patients with traumatic cervical spinal cord injury (SCI).

Methods: This was a randomized, double blind, placebo controlled clinical trial being performed in Nemazee and Shahid Rajaei hospitals of Shiraz during a 3-year period from 2011 to 2014. A total number of 20 patients with acute traumatic cervical SCI less than 8 hours after injury were included. We excluded those with anatomic cord dissection, penetrating cord injury and significant concomitant injury. Patients were randomly assigned to receive rhEPO in 500IU/mL dosage immediately and 24-hour later (n=11) or placebo (n=9). All the patient received standard regimen of methylprednisolone. Neurological function was assessed on admission, 1, 6 and 12 months after the injury according to the American Spinal Cord Injury Association (ASIA).

Results: Overall we include a total number of 20 patients. The mean age of the patients was found to be 40.1 ± 9.5 (ranging from 19 to 59) years. There were 18 (90.0%) men and 2 (10.0%) women among the patients. There was no significant difference between two study groups regarding the baseline characteristics. The baseline ASIA score was comparable between two study groups. The motor and sensory ASIA scores were comparable between two study groups after 1, 6 and 12 months follow-ups. We also found that there was no significant difference between two study groups regarding the motor and sensory outcome in complete cord injury and incomplete cord injury subgroups.

Conclusion: Administration of rhEPO does not improve the functional outcome of patients with traumatic cervical SCI.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 65 years(—)
性别
All

入选标准

  • Acute cervical cord injury Less than 8 hours from injury.
  • Exclusion criteria: Anatomic cord dissection; Penetrating cord injury; Injury beyond cervical cord; Significant concomitant injury; Contraindication for methylprednisolone; Contraindication for erythropoietin; Patient refuses the study

排除标准

  • 未提供

研究者

发起方
Shiraz University of Medical Science

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