The aim of the present study is to determine the effects of high dose recombinant erythropoietin (EPO) during eight hours after traumatic cervical spinal cord injury on functional outcome. A total of 20 patients with acute traumatic cervical spinal cord injury less than 8 hours after injury were included. We excluded those with anatomic cord dissection, penetrating cord injury and significant concomitant injury. Patients will randomly assigned to receive recombinant EPO in 500IU/mL dosage immediately and 24-hour later (n=10) or placebo (n=10). To assess improvement from baseline, neurological function will be assessed and scored at month 1, 6 and 12 using the American Spinal Cord Injury Association (ASIA) standardized neurological examination, including the motor and sensory composites.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122920471N1
Registration date:2015-04-26, 1394/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-26, 1394/02/06
Registrant information
Name
Mohammad Hossein Ashraf
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 4259
Email address
ashrafmh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Human Recombinant Erythropoietine on Functional Outcome of Traumatic Cervical Spine Cord Injury; A Randomized Placebo Controlled Study
Public title
Effects of human erythropoietine in improvement of traumatic cervical cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical science
Street address
Zand Ave
City
Shiraz
Postal code
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
CT-92-4315
Health conditions studied
1
Description of health condition studied
Traumatic Cervical Cord Injury
ICD-10 code
S14
ICD-10 code description
Injury of nerves and spinal cord at neck level
Primary outcomes
1
Description
Neurological examination
Timepoint
Before, 1,3,6 months after intervention
Method of measurement
examining by physician
Secondary outcomes
empty
Intervention groups
1
Description
recombinant erythropoietin, intravenous, 500 IU, stat and repeat that after 24 hour
Category
Treatment - Drugs
2
Description
equal volume of normal saline, intravenous, stat and 24 hour later
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Mohammad Hossein Ashraf
Street address
Shahid Rajaei Hospital, Chamran Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Vice Chancellor of Research
Street address
7th Floor, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?