Comparing the efficacy of the intrathecal with intravenous Methylprednisolone administration in outcome of patients with acute thoracolumbar spinal cord injury (SCI)
determination of the efficacy of the intrathecal with intravenous methyl prednisolone administration in outcome of patients with acute thoracolumbar spinal cord injury (SC I)
Design
60 patients with acute spinal cord injuries will be selected for inclusion in the study, in accordance with the criteria for entry and exit. Patients will be divided into two groups in the first 8 hours of referral, so that 30 patients will be in the group receiving intraluminal methylprednisolone and 30 in the intravenous methylprednisolone group. To randomly select patients for study groups, a box will be designed. The patients will then be fully examined for signs and symptoms of the disease and for neurological performance in the sensory and motorway. .
After performing the first steps and patient segmentation, patients in the first group will receive intravenous prednisolone and the second in the spinal cord.
Settings and conduct
Tabriz Imam Reza Hospital
Participants/Inclusion and exclusion criteria
Entry criteria:
- Patients with acute spinal cord injury in the thoracolumbar region (Frankel A B C D degree)
- Patients referred in the first 8 hours after injury
Exit criteria:
- Patients with nerve spinal cord injury or single injury Cauda equina
- Damage following bullet injury
- life-threatening injuries
- Pregnant patients
- Drug addicts or narcotics
- Patients taking steroids for other reasons
- Patients under 13 years of age
- Contraindications for LP and any traumatic brain injury
Intervention groups
In this study, patients in the first 8 hours of referral will be randomized into two groups of study, so that 30 patients will be in the group receiving intraluminal methylprednisolone and 30 subjects will be treated with intravenous methylprednisolone .
Main outcome variables
Sensory signs Symptoms of gastrointestinal tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190116042374N1
Registration date:2019-02-04, 1397/11/15
Registration timing:registered_while_recruiting
Last update:2019-02-04, 1397/11/15
Update count:0
Registration date
2019-02-04, 1397/11/15
Registrant information
Name
Morteza Khalilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 3871
Email address
khalilzadem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of the intrathecal with intravenous Methylprednisolone administration in outcome of patients with acute thoracolumbar spinal cord injury (SCI)
Public title
Effect of Methylprednisolone in acute spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All traumatic patients with acute thoracolumbar spinal cord injury
Age over 13 years
Exclusion criteria:
Patients with nerve spinal cord injury or single injury Cauda equina
Damage after injury with bullets
Pregnant patients
Patients receiving steroids for other reasons
Patients under 13 years of age
Patients with a history of receiving 100 mg of Methylprednisolone or a diet equal to it
Diabetic patients
Patients with immunodeficiency
Patients Needing Emergency Surgery
Loss of consciousness
LP contraindications and any traumatic lesions of the brain
Age
From 13 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the selection of patients for study groups, a box will be designed that will include 60 envelopes in the box, 30 of which are interattakal treatment, and 30 of which are intravenous treatment, which, after Referring to the patient, the resident examiner, he will randomly remove one of the papers from the box and place the patient in the group written on the paper.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be randomly assigned to one of the intrathecal or intravenous groups without knowing how to assign the intervention method. The researcher will use the method of randomization using the random sampling method to remove the envelope and will be unaware of how the intervention method is allocated. An analyst will be unaware of how the intervention was performed, and based on this study, the three-blind study will be analyzed and analyzed after the analysis of the results based on the randomized map.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Street.,Azadi Ave.,Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.TBZMED.REC.1396.971
Health conditions studied
1
Description of health condition studied
A 48-hour regimen with methyl prednisolone in patients with acute spinal cord injuries significantly improves neurological symptoms in patients.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The evaluation of peroxidation metabolites (TAC) total antioxidant capacity (MDA) and malondialdehyde (MDA), which indicates the inflammatory status of the spinal cord, as well as sensory and motor status assessment based on ASIA and FRANKL grading at discharge
Timepoint
Patients will undergo a re-examination and assessment of sensory and motor status in three intervals at the time of discharge (day 7-10) of the sixth week (day 42-49) and the sixth month (day 180-150)after treatment. On day 1 and 4 of admission, total antioxidant capacity and malondialdehyd (TAC and MDA)is measured.
Method of measurement
The sensory and motor status of the patient is measured at each turn with the examination and total antioxidant capacity and malondialdehyd metabolites in the laboratory by the device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Traumatic patients with acute spinal cord injuries injected intrathecal Methylprednisolone acetate with a dose of 1 mg per kg and this treatment protocol will be repeated 24 and 48 hours later.
Category
Treatment - Drugs
2
Description
Control group: Acute spinal injury trauma patients receiving intravenous Methylprednisolone acetate will receive a dose of intravenous bolus Methylprednisolone at a dose of 30 mg per kg body weight over a period of 15 minutes. Then, after a 45-minute delay, the dose The intravenous dose of 5.4 mg / body weight will be continued for 47 hours at the start of the first bolus dose for the first 3 hours, for 23 hours and starting at 3-8 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Ali Meshkini
Street address
Golgasht street,.Azadi Ave,.Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7058
Email
khalilzadem@tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golgasht street,.Azadi ave,.Tabriz University of Medical siences,Deputy of research and technology
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golgasht street,.Azadi Ave,.Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7058
Email
Meshkinia@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golgasht street,.Azadi Ave,.Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7058
Email
Meshkinia@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golgasht street,.Azadi Ave,.Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7058
Email
Meshkinia@tbzmed.ac.ir
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