Effects of human erythropoietine in improvement of traumatic cervical cord injury

Phase 2

Conditions: Traumatic Cervical Cord Injury.
Injury of nerves and spinal cord at neck level

Registration Number: IRCT2014122920471N1

Lead Sponsor: Shiraz University of Medical Science

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

Not provided