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IRCT20120527009878N15 IRCT 2022-09-10 Tabriz University of Medical Sciences minocycline on the neurological outcome The effect of minocycline on the neurological outcome of spinal cord injury patients 2022-10-07 anticipated 54 Complete https://irct.ir/trial/65339 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, and BAAB. For selecting each block, dice drooped and the block number will be selected. this procedure continued to complete the allocation and reached to sample size, Blinding description: This is a double-blinded study and Researchers and patients are kept unaware of the intervention in each group In order to allocate concealment, the type of intervention will be written on paper and placed in numbered, matte, and packed envelopes. The envelopes will be opened in the order of participation of the participants and the type of group will be determined. 2 Spinal Injury. Intervention 1: Intervention group: will receive bolus infusion of methylprednisolone 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolone for 23-42 hours and 50mg minocycline orally every 12 hours for 1 week. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: Neuropsychiatric specialists in coordination with the presenter Conditions: The use of data to improve patients' treatment processes is safe Where to obtain: The person responsible for updating study information How to obtain: Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public Dr.Farhad Mirzaei
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 0830 golzar.farhad@yahoo.com Tabriz University of Medical Sciences scientific Dr Ali Meshkini
Neurosurgery ward,Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Gholghasht Street, Azadi Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 meshkinia@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with spinal cord injury from T10 to L2 Patients with age of 18 to 60 Frankle grade A to D 18 years 60 years Both Patients older or younger than 17-60; Patients with head trauma and GCS score lower than 13 Reaction to Minocycline use Spinal cord injury out of T10 to L2 Trials S34.1 Other and unspecified injury of lumbar and sacral spinal cord Treatment - Surgery Treatment - Drugs Intervention group: will receive bolus infusion of methylprednisolone 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolone for 23-42 hours and 50mg minocycline orally every 12 hours for 1 week 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. Investigation of Neurological status based on Frankel Grade. Timepoint: At admission and 6-month period after admission. Method of measurement: Based on Frankel grade. Tabriz University of Medical Sciences Approved 2019-11-25 Ethics Committee of Tabriz Medical School Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)