Aim: Investigation of Effects of intravenous ceftriaxone in neurologic outcome of acute spinalcord injury patients compared with methylprednixolone alone
Study design: Randomized Two-blinded clinical trial study
Object Study: Patients with spinal cord injury refereed to Imam Reza hospital of Tabriz University of medical Sciences less than 8 hours after accident
Inclusion criteria:Patients with spinal cord injury from T10 to L2; Patients with age of 17 to 60 ; Frankle grade A to D
Exclusion criteria: Patients older or younger than 17-60; Patients with head trauma and GCS score lower than 13; Reaction to Ceftriaxone use; Amp Calcium intake or other drugs with calcium ; First trimester; E grade based on Frankel classification at admission; Spinal cord injury out of T10 to L2
Trials: After informed consent were obtained; all patients divided in two group randomly and frankel grading and Check of ESR and CRP obtained at admission. All patients will receive bolus infusion of methylprednisolon 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolon for 23-42 hours. Case group will receive 2 g ceftriaxon intra venous each 12 hours for 1 week.
ESR, CRP and frankle grade in 1,4,7 6 months follow upwill be taken days after admission and data will analysed to campare between two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102713947N5
Registration date:2017-02-11, 1395/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Atta Mahdkhah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 6196
Email address
mshimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Road traffic injury prevention research center, Tabriz University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intravenous ceftriaxone in neurologic outcome of acute spinalcord injury patients compared with methylprednixolone alone
Public title
Effects of intravenous ceftriaxone in neurologic outcome of acute spinalcord injury patients compared with methylprednixolone alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with spinal cord injury from T10 to L2; Patients with age of 17 to 60 ; Frankle grade A to D
Exclusion criteria: Patients older or younger than 17-60; Patients with head trauma and GCS score lower than 13; Reaction to Ceftriaxone use; Amp Calcium intake or other drugs with calcium ; First trimester; E grade based on Frankel classification at admission; Spinal cord injury out of T10 to L2
Age
From 17 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Technology and Research,Tabriz University of Medical Sciences
Street address
Tabriz
City
Tabriz
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.TBZMED. REC.1395.434
Health conditions studied
1
Description of health condition studied
Spinal Injury
ICD-10 code
ُS34.1
ICD-10 code description
Other injury of lumbar spinal cord
Primary outcomes
1
Description
Investigation of Neurological status based on Frankel Grade
Timepoint
At admission and 6 month period after admission
Method of measurement
Based on Frankel grade
Secondary outcomes
empty
Intervention groups
1
Description
Case group will receivebolus infusion of methylprednisolon 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolon for 23-42 hours and 2 g ceftriaxon intra venous each 12 hours for 1 week
Category
Treatment - Drugs
2
Description
control group will receive bolus infusion of methylprednisolon 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolon for 23-42 hours.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Road traffic injury prevention research center, Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Road traffic injury prevention research center, Tabriz 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
Department of Neurosurgery, Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Position
professor
Other areas of specialty/work
Street address
Tabriz
City
tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
meshkinia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of neurosurgery, Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Position
Professor
Other areas of specialty/work
Street address
Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
meshkinia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Neurosurgery, Tabriz University of Medical Sciences
Full name of responsible person
Meshkini Ali
Position
Professor
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
meshkinia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)