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IRCT20190116042374N1 IRCT 2019-02-04 Tabriz University of Medical Sciences Effect of Methylprednisolone in acute spinal cord injury Comparing the efficacy of the intrathecal with intravenous Methylprednisolone administration in outcome of patients with acute thoracolumbar spinal cord injury (SCI) 2018-10-22 anticipated 60 Complete https://irct.ir/trial/36905 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 A 48-hour regimen with methyl prednisolone in patients with acute spinal cord injuries significantly improves neurological symptoms in patients.. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ali Meshkini
Golgasht street,.Azadi Ave,.Emam Reza hospital
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7058 Meshkinia@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ali Meshkini
Golgasht street,.Azadi Ave,.Emam Reza hospital
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7058 Meshkinia@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) All traumatic patients with acute thoracolumbar spinal cord injury Age over 13 years 13 years no limit Both 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 Treatment - Drugs Treatment - Drugs 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. 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. 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. Tabriz University of Medical Sciences Approved 2018-01-14 Ethics committee of Tabriz University of Medical Sciences Golgasht Street.,Azadi Ave.,Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)