This study was aimed to investigate the effect of recombinant human erythropoietin (rhEPO) on functional outcome and disability in patients with traumatic cervical spinal cord injury (TCSCI).
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence
Settings and conduct
Patients with acute traumatic cervical spinal cord injury admitted within 8 hours after injury were randomly assigned into two groups and either received only the standard regimen of methylprednisolone or rhEPO plus the standard regimen of methylprednisolone. All the patients underwent the surgery within the next several days. Neurological function was assessed on admission, and at 6th and 12th months after the injury.
The patients and the people responsible for data collection and analysis were blinded. The assignment of patients was concealed using sealed envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with traumatic cervical spinal cord injury were included.
Exclusion criteria: patients with current or past history of cardiovascular, neurological, psychiatric and renal disease, pregnant and lactating women, and those with allergy to erythropoietin or human albumin were excluded.
Intervention groups
The control group received only the standard regimen of methylprednisolone and the intervention group received rhEPO 500IU/mL plus the standard regimen of methylprednisolone.
Main outcome variables
َAmerican Spinal Injury Association (ASIA) score, mortality, Sphincter function after 6 and 12 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041103N1
Registration date:2020-02-09, 1398/11/20
Registration timing:retrospective
Last update:2020-02-09, 1398/11/20
Update count:0
Registration date
2020-02-09, 1398/11/20
Registrant information
Name
Mohammad Ali abouei mehrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 9451
Email address
drabouei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-12-19, 1394/09/28
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
2015-12-19, 1394/09/28
Actual recruitment end date
2016-03-18, 1394/12/28
Trial completion date
2017-04-19, 1396/01/30
Scientific title
Evaluating the effects of combination therapy with Erythropoietin and Methylprednisolone in patients with traumatic cervical spinal cord injury
Public title
The effect of erythropoietin on acute spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Acute Traumatic Cervical Spinal Cord Injury
Admitted within 8 hours of injury
Neurological lesion at C5 to C7 level
Stable hemodynamics
Exclusion criteria:
Vascular Brain Disease
Acute Myocardial Infarction
Thrombotic Diseases
Cardiac Arrhythmia
Heart Failure
Peripheral Vascular Disorders
Polycythemia
Porphyria
Malignancy
Neurological Disorders
Known Psychiatric Disorders
Acute or Chronic Kidney Disease
Acute Spinal Cord Injury caused by weapons
Pregnancy
Lactation
Allergy to Erythropoietin or Human Albumin
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible patients were assigned to control and intervention groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the people responsible for data collection and analysis were blinded. The assignment of patients was concealed using sealed envelopes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah St., central building of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.MUMS.REC.1394.574
Health conditions studied
1
Description of health condition studied
Traumatic Cervical Spinal Cord Injury
ICD-10 code
S14
ICD-10 code description
Injury of nerves and spinal cord at neck level
Primary outcomes
1
Description
American Spinal Injury Association (ASIA) score
Timepoint
Baseline, 6 and 12 months after intervention
Method of measurement
Medical History and Physical Examination
2
Description
Sphincter Function
Timepoint
Baseline, 6 and 12 months after intervention
Method of measurement
Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: methyl prednisolone (500 mg lyophilized vials, Ronak Daroo, Iran), 30 mg/kg IV infusion for the first hour followed by 5.4 mg/kg/h in the next 23 hours if referred within 3 hours of injury; or if referred to the ED between the third and eighth hour after the trauma underwent treatment based on National Acute Spinal Cord Injury Study (NASCIS) III protocol for the following 47 hours.
Category
Treatment - Drugs
2
Description
Intervention group: underwent treatment with both methyl prednisolone (500 mg lyophilized vials, Ronak Daroo, Iran), based on the NASCIS III protocol and erythropoietin (10000 U ampules, CinnaGen, Iran), 500 IU/kg in 50 ml of saline solution being infused over 30 minutes and the treatment continued in the next 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Abouei Mehrizi
Street address
Shahid Kamyab Hospital, Fadaeyan Eslam St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3859 2121
Email
skh.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central building of Mashhad University of Medical Sciences, Daneshgah 16, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Bahadoorkhan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Ghaem hospital, Ahmad Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
bahadorkhangh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Bahadoorkhan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Ghaem hospital, Ahmad Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
bahadorkhangh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Abouei Mehrizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shahid Kamyab hospital, Fadaeyan Eslam St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3859 2121
Email
drabouei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available