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Comparison of the efficacy of erythropoietin and methyl prednisolone in improving muscle strength or sensory level outcomes in patients with spinal cord injury.

Protocol summary

Summary
The aim of the study: to evaluate the improvement of sensory and muscle strength in patients with spinal cord injury and enzyme changes, malondialdehyde, and total antioxidant capacity in the two groups., Double-blind study conducted in 60 patients with traumatic spinal cord injury complications decreased muscle strength or sensory level according to Frankel classification A - E and during first 24 hours of trauma have been admitted in Emamreza hospital. admission status, sensory, motor, according to Frankel classification has been is performed, blood samples To check the amount of enzyme, malondialdehyde and total antioxidant capacity will be taken . The bullous form of methylprednisolone 33mg/kg intravenous infusion within fifteen minutes and after 45 minute, 5.4mg/kg methylprednisolone infusion within 23-47 hours, will continue. Patients were divided into two groups, the first group of methylprednisolone, after obtaining the consent of the patient, erythropoietin, or 500 units per kilogram of body weight as an intravenous infusion over 3 divided doses in three days will be in the second group further treatment will not be added. , In both groups, the rate of enzyme levels, muscle strength, and sensory level at the fourth and eighth days will be check. Inclusion criteria: patients with spinal cord injury and loss of muscle strength and sensory . Exclusion criteria: patients with hypertension poor control ,history of thromboembolic events, patients with brain damage due to a lower GCS determination of the patient's sensory and motor. Variables assessed: Evaluation of malondialdehyde and antioxidant enzyme levels and muscle weakness and sensory level is classified as Frankel .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041417272N1
Registration date: 2014-07-04, 1393/04/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Nasrin Pourhajshokr
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 354 4705
Email address
ebrahimin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences, Center for Neuroscience Research
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of erythropoietin and methyl prednisolone in improving muscle strength or sensory level outcomes in patients with spinal cord injury.
Public title
Efficacy of Intravenous erythropoietin in patients with spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who develop symptoms of spinal cord injury and decrease muscle strength or sensory level deficit Frankel classification A - E Exclusion criteria: Patients with uncontrolled hypertension, patients allergic to human albumin, Pregnancy and lactation, erythroid leukemia, Patients with a history of thromboembolic events. in patients with severe coronary artery disease , peripheral arteries, the carotid"brain,brain-damaged patients with low GCS due to lack of accurate sensory, motor cases
Age
From 1 year old to 100 years old
Gender
Both
Phase
N/A
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
Tabriz University of Medical Science
Street address
2 Central Building, Deputy of Research and Tecnology, Tabriz University of Medical Science, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
3844/4/5

Health conditions studied

1

Description of health condition studied
Spinal cord injury
ICD-10 code
G90-G99 اخ
ICD-10 code description
G95.2 كمپرشن كانال نخاعي

Primary outcomes

1

Description
The muscle strength scoring Franklin A-E
Timepoint
Admission, fourth day of admission, the eighth day of admission
Method of measurement
Examination by resident Brain surgery

2

Description
The sensory strength scoring Franklin A-E
Timepoint
Admission, fourth day of admission, the eighth day of admission
Method of measurement
Examination by resident Brain surgery

Secondary outcomes

1

Description
The level of enzyme levels, total Antioxidant capacity
Timepoint
Admission, Fourth day of admission, Eight day of admission
Method of measurement
Kerry measured by enzymatic kits for lab

2

Description
The level of enzyme levels, Malon dy Aldehid
Timepoint
Admission, Fourth day of admission, Eight day of admission
Method of measurement
Kerry measured by enzymatic kits for lab

Intervention groups

1

Description
Methylprednisolone 33mg/kg were referred to as bullous within fifteen minutes then 5.4mg/kg methylprednisolone infusion within 23-47 hours.
Category
Treatment - Drugs

2

Description
Intervention group.First Methylprednisolone 33mg/kg were referred to as bullous within fifteen minutes then 5.4mg/kg methylprednisolone infusion within 23-47 hours. then Erythropoietin 500 units per kg of body weight as an intravenous infusion over 3 days will be given in 3 divided doses
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Dr nasrin pourhajshokr
Street address
Imam Reza Hospital, Golgasht street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, MediCenter for Neuroscience Research
Full name of responsible person
Dr Ali Meshkini
Street address
2 Central Building, Deputy of Research and Technology, Imam Reza Hospital, Tabriz University of Medical Sciences
City
Tabriz
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, MediCenter for Neuroscience Research
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
Tabriz University of Medical Sciences
Full name of responsible person
Nasrin Pourhajshokr
Position
Surgical Residency in Neurology
Other areas of specialty/work
Street address
Golgasht street, Emamreza Hospital, Tabriz University of Medical Sciences
City
Tabriz
Postal code
4164164163
Phone
+98 41 1334 7054
Fax
Email
nasrinpour2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Meshkini
Position
Weston spine Surgeon Specializing in diseases of the brain and nerves - Fellowship of the Stereotact
Other areas of specialty/work
Street address
Golgasht street, Eemamreza Hospital
City
Tabriz
Postal code
4164164163
Phone
+98 41 1334 7054
Fax
Email
meshkinia@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nasrin Purhajshokr
Position
Surgical Residency in Neurology
Other areas of specialty/work
Street address
Golgasht strert، Emamreza Hospital
City
Tabriz
Postal code
4164164163
Phone
+98 4119143544705
Fax
Email
nasrinpour2000@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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