A comparison between therapeutic effect of granulocyte colony-stimulating factor and methylprednisolone on sensory and motor function in patients with acute traumatic spinal cord injury
This study aims to evaluate and compare the therapeutic effect of granulocyte colony-stimulating factor (G-CSF) and methylprednisolone on sensory and motor function in patients with acute traumatic spinal cord injury. In a randomized clinical trial patients between 18 to 65 years old with acute (48 hours after trauma) traumatic spinal cord injury, will be enrolled according to inclusion criteria. Before the intervention spinal cord injury grade will be assessed according to ASIA impairment scale (AIS) and Sensory and motor function score will be assessed according to American Spinal Injury Association (ASIA) scoring system. Ninety two patients will be divided into intervention or control group in a randomized block design. The Intervention group will be treated by intravenous infusion of 10 microgram/kg/day of G-CSF for 5 consecutive days and the control group will receive standard treatment of high dose of methylprednisolone. Follow up evaluations will be done on 1 week after the intervention, 3 months after the intervention and 6 months after the intervention.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201504077369N2
Registration date:2015-08-17, 1394/05/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-17, 1394/05/26
Registrant information
Name
Firouz Behboudi
Name of organization / entity
Gilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8773
Email address
info@gtrc.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Guilan University of Medical Sciences
Expected recruitment start date
2013-05-29, 1392/03/08
Expected recruitment end date
2014-05-29, 1393/03/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between therapeutic effect of granulocyte colony-stimulating factor and methylprednisolone on sensory and motor function in patients with acute traumatic spinal cord injury
Public title
Therapeutic effect of granulocyte colony-stimulating factor in patients with acute traumatic spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Acute traumatic spinal cord injury; Age between 18 to 65 years old
Exclusion criteria: Presence of intracranial lesions such as tumor, infection, ischemia or trauma; Past history of massive blood loss with transfusion; Past history of leukopenia or thrombocytopenia; Past history of hepatic or renal dysfunction; Past history of sever heart failure; Presence of splenomegaly or past history of it; Any evidence of malignancy during past 5 years; Pregnancy or lactation
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:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients are divided into intervention or control groups by randomized block design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences,West Shahid Beheshti Blv, in front of Bank Sepah, Top floor of Iran Radiator agency, Rasht, Iran
City
Rasht
Postal code
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
1930596707
Health conditions studied
1
Description of health condition studied
Traumatic spinal cord injury
ICD-10 code
V01-V99
ICD-10 code description
Transport accidents
2
Description of health condition studied
Traumatic spinal cord injury
ICD-10 code
W00-X59
ICD-10 code description
Other external causes of accidental injury
3
Description of health condition studied
Traumatic spinal cord injury
ICD-10 code
S24.1
ICD-10 code description
Other and unspecified injuries of thoracic spinal cord
4
Description of health condition studied
Traumatic spinal cord injury
ICD-10 code
S14.1
ICD-10 code description
Other and unspecified injuries of cervical spinal cord
5
Description of health condition studied
Traumatic spinal cord injury
ICD-10 code
T91.3
ICD-10 code description
Sequelae of injury of spinal cord
Primary outcomes
1
Description
Spinal cord injury grade
Timepoint
Before the intervention, 1 week after the intervention, 3 months after the intervention and 6 months after the intervention
Method of measurement
AIS grading system
2
Description
Sensory and motor function score
Timepoint
Before the intervention, 1 week after the intervention, 3 months after the intervention and 6 months after the intervention
Method of measurement
ASIA scoring system
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intravenous infusion of 10 microgram/kg/day G-CSF for 5 consecutive days
Category
Treatment - Drugs
2
Description
Methylprednisolone is given as an initial intravenous bolus of 30 mg/kg administered over a period of 15 minutes. This is followed 45 minutes later by a 5.4 mg/kg per hour continuous infusion of methylprednisolone. If treatment is initiated within 3 hours of injury, the infusion is continued for 23 hours; if treatment is begun between 3 to 8 hours after injury, the infusion is continued for 47 hours (for a total of 48 hours).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Poursina Hospital
Full name of responsible person
Siavash Dehghani
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences,West Shahid Beheshti Blv, in front of Bank Sepah, Top floor of Iran Radiator agency, Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Siavash Dehghani
Position
Senior Resident of Neurosurgery
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, Rasht, Iran
City
Rasht
Postal code
Phone
+98 918 832 4416
Fax
Email
dr.sia_sur@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shahrokh Yousefzadeh-Chabok
Position
Professor of Neurosurgery
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, University of Guilan, 6 Km after Rasht-Tehran Highway, Rasht, Iran
City
Rasht
Postal code
Phone
+98 911 333 0670
Fax
Email
sh.yousefzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Siavash Dehghani
Position
Senior resident of Neurosurgery
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, University of Guilan, 6 Km after Rasht-Tehran Highway, Rasht, Iran
City
Rasht
Postal code
Phone
Fax
Email
dr.sia_sur@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)