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IRCT201504077369N2 IRCT 2015-08-17 Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Therapeutic effect of granulocyte colony-stimulating factor in patients with acute traumatic spinal cord injury - A comparison between therapeutic effect of granulocyte colony-stimulating factor and methylprednisolone on sensory and motor function in patients with acute traumatic spinal cord injury 2013-05-29 anticipated 92 Complete https://irct.ir/trial/7814 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients are divided into intervention or control groups by randomized block design. 2 Condition 1: Traumatic spinal cord injury. Condition 2: Traumatic spinal cord injury. Condition 3: Traumatic spinal cord injury. Condition 4: Traumatic spinal cord injury. Condition 5: Traumatic spinal cord injury. Intervention 1: Intravenous infusion of 10 microgram/kg/day G-CSF for 5 consecutive days. Intervention 2: Methylprednisolone is given as an initial intravenous bolus of 30 mg/kg administered over a period of 15 minutes. This is followed 45 minutes later by a 5.4 mg/kg per hour continuous infusion of methylprednisolone. If treatment is initiated within 3 hours of injury, the infusion is continued for 23 hours; if treatment is begun between 3 to 8 hours after injury, the infusion is continued for 47 hours (for a total of 48 hours).
public Siavash Dehghani
Guilan University of Medical Sciences, Rasht, Iran
Rasht Iran (Islamic Republic of) +98 918 832 4416 dr.sia_sur@yahoo.com Guilan University of Medical Sciences scientific Shahrokh Yousefzadeh-Chabok
Guilan University of Medical Sciences, University of Guilan, 6 Km after Rasht-Tehran Highway, Rasht, Iran
Rasht Iran (Islamic Republic of) +98 911 333 0670 sh.yousefzadeh@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Acute traumatic spinal cord injury; Age between 18 to 65 years old Exclusion criteria: Presence of intracranial lesions such as tumor, infection, ischemia or trauma; Past history of massive blood loss with transfusion; Past history of leukopenia or thrombocytopenia; Past history of hepatic or renal dysfunction; Past history of sever heart failure; Presence of splenomegaly or past history of it; Any evidence of malignancy during past 5 years; Pregnancy or lactation 18 years 65 years Both V01-V99 W00-X59 S24.1 S14.1 T91.3 Transport accidents Other external causes of accidental injury Other and unspecified injuries of thoracic spinal cord Other and unspecified injuries of cervical spinal cord Sequelae of injury of spinal cord Treatment - Drugs Treatment - Drugs Intravenous infusion of 10 microgram/kg/day G-CSF for 5 consecutive days Methylprednisolone is given as an initial intravenous bolus of 30 mg/kg administered over a period of 15 minutes. This is followed 45 minutes later by a 5.4 mg/kg per hour continuous infusion of methylprednisolone. If treatment is initiated within 3 hours of injury, the infusion is continued for 23 hours; if treatment is begun between 3 to 8 hours after injury, the infusion is continued for 47 hours (for a total of 48 hours). Spinal cord injury grade. Timepoint: Before the intervention, 1 week after the intervention, 3 months after the intervention and 6 months after the intervention. Method of measurement: AIS grading system. Sensory and motor function score. Timepoint: Before the intervention, 1 week after the intervention, 3 months after the intervention and 6 months after the intervention. Method of measurement: ASIA scoring system. -. Timepoint: -. Method of measurement: -. Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Approved 2015-02-24 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for Research and Technology of Guilan University of Medical Sciences,West Shahid Beheshti Blv, in front of Bank Sepah, Top floor of Iran Radiator agency, Rasht, Iran Rasht Iran (Islamic Republic of)