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Trial registered on ANZCTR


Registration number
ACTRN12609000602224
Ethics application status
Approved
Date submitted
19/07/2009
Date registered
21/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Erythropoietin plus methylprednisolone versus methylprednisolone plus placebo in the treatment of acute spinal cord injury: A pilot study
Scientific title
A randomized clinical trial on comparison of erythropoietin plus methylprednisolone versus methylprednisolone plus placebo in the improvement of neurologic outcome after acute spinal cord injury
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute spinal cord injury 237292 0
Condition category
Condition code
Injuries and Accidents 239617 239617 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methylprednisolone sodium succinate intravenously 30 mg/kg on admission and 5.4 mg/kg every hour till 23 hours(if admitted within 3 hours after injury) and till 47 hours (if admitted between 3-6 hours after injury) plus intravenous injection of 500 unit/kg of recombinant human erythropoietin in 500 ml normal saline on admission and another 500 unit/kg of recombinant human erythropoietin in 500 ml normal saline 24 hours later
Intervention code [1] 236969 0
Treatment: Drugs
Comparator / control treatment
Methylprednisolone sodium succinate intravenously 30 mg/kg on admission and 5.4 mg/kg every hour till 23 hours(if admitted within 3 hours after injury) and till 47 hours (if admitted between 3-6 hours after injury) plus intravenous injection of 500 ml of normal saline on admission and another 500 ml of normal saline 24 hours later
Control group
Placebo

Outcomes
Primary outcome [1] 238404 0
Neurologic examination for determination of American Spinal Injury Association (ASIA) scale
Timepoint [1] 238404 0
on admission,24 and 48 hours, one week, one and six months later
Secondary outcome [1] 244878 0
Rectal sphincter tone presence evaluated by rectal examination
Timepoint [1] 244878 0
on admission and one month later

Eligibility
Key inclusion criteria
Spinal cord injury presenting to emergency department within 6 hours after injury
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
only qauda equina or nerve root involvement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
drawing numbered cards
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1908 0
Iran, Islamic Republic Of
State/province [1] 1908 0
Fars

Funding & Sponsors
Funding source category [1] 237354 0
Commercial sector/Industry
Name [1] 237354 0
Pooyesh Darou
Address [1] 237354 0
No. 37, 5th Avenue
Fatemi Street
Tehran
Country [1] 237354 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shiraz University of Medical Sciences
Address
Zand Blvd.
71345-1978
Shiraz
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 236847 0
Commercial sector/Industry
Name [1] 236847 0
Pooyesh Darou
Address [1] 236847 0
No. 37, 5th Avenue
Fatemi Street
Tehran
Country [1] 236847 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239483 0
Shiraz University of Medical Sciences ethics committee
Ethics committee address [1] 239483 0
Ethics committee country [1] 239483 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 239483 0
Approval date [1] 239483 0
Ethics approval number [1] 239483 0

Summary
Brief summary
This study aimed to evaluate the effectiveness of intravenous human recombinnant erythropoietin plus methylprednisolone versus methylprednisolone alone to improve neurologic outcome during a six month follow-up after traumatic cord injury
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29926 0
Address 29926 0
Country 29926 0
Phone 29926 0
Fax 29926 0
Email 29926 0
Contact person for public queries
Name 13173 0
Farid Zand
Address 13173 0
Department of Anesthesiology
Nemazee Hospital
Nemazee Square
71937-11351
Country 13173 0
Iran, Islamic Republic Of
Phone 13173 0
+98-711-233-7636
Fax 13173 0
+98-711-231-8072
Email 13173 0
zandf@sums.ac.ir
Contact person for scientific queries
Name 4101 0
Farid Zand
Address 4101 0
Department of Anesthesiology
Nemazee Hospital
Nemazee Square
71937-11351
Country 4101 0
Iran, Islamic Republic Of
Phone 4101 0
+98-711-233-7636
Fax 4101 0
+98-711-231-8072
Email 4101 0
zandf@sums.ac.ir

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary