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IRCT20200815048418N1 IRCT 2020-12-12 Ahvaz University of Medical Sciences Evaluation of the effect of glibenclamide in patients with traumatic diffuse brain injuries Evaluation of the effect of glibenclamide on improving the treatment results and consciousness of patients with traumatic brain diffuse axonal injury 2019-02-18 anticipated 96 Complete https://irct.ir/trial/50438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, all patients during the study period will be equally and randomly divided into case and control groups and will enter the study. Randomization of study samples will be done in two groups by random allocation. For this purpose, we first determine the total sample size, then randomly assign a set of them to group A and the rest to group B. we do this using a table of random numbers. In assigning patients to two hidden groups Random sequencing will be considered throughout the process and the patient and researcher will not be aware of the group the patient is entering. Awareness of subsequent allocation may lead to the elimination of specific patients by the researcher based on their disease prognosis, or patients with better conditions enter the intervention group and patients with worse conditions enter the control group, Blinding description: In this study, participants were kept blind to being in the intervention group or control group. Patients were assured that their information would be kept strictly confidential. Patients were given full explanations about the objectives, method of implementation of the plan and its possible side effects, and if they or their legal guardians were willing, consent was obtained and included in the study. They were blind from being in any of intervention or control groups. 3 traumatic brain injury. Intervention 1: Intervention group: daily 10 mg glibenclamide for 10 days. Intervention 2: Control group: placebo Prescription. 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 there is no more information.
public Hesam Rasoulian
Esfand street
Ahvaz Iran (Islamic Republic of) 6135715794 009833114155 hr9473.hr@gmail.com Ahvaz University of Medical Sciences scientific Hesam Rasoulian
Esfand street
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 4155 hr9473.hr@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) All TBI patients with moderate(9-12)to severe(4-8) GCS referred to the emergency department of Golestan Hospital in Ahvaz with a maximum of 24 hours after TBI. 18 years no limit Both Patients with diabetes mellitus, patients that required surgery, spinal cord injury, patients with any known history of renal or hepatic diseases, patients with past medical history of brain tumors, blood glucose <50 g/dL or >500 mg/dL on admission; internal organs diseases, penetrating brain injury, creatinine >2.5mg/dL or on hemodialysis, total bilirubin >1.5 times of normal value, infections, or previous craniotomy; pregnant patients or patients who intended to breastfeed after being discharged; patients with international normalized ratio >1.5 or use of antiplatelets or anti coagulants within 7 days before admission, history of glucose-6-phosphate dehydrogenase deficiency or any diagnosed allergy to sulfonylurea; patients with contusions in brainstem or an systolic blood pressure <90 mm Hg without response to fluid resuscitation; and patients with contraindications to oral route for taking the medication or treatment with other investigational agents during hospitalization. S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: daily 10 mg glibenclamide for 10 days. Control group: placebo Prescription Glasgow outcome scale. Timepoint: Three months after TBI. Method of measurement: Glasgow outcome scale. Ahvaz University of Medical Sciences Approved 2019-02-16 Ethics committee of Ahvaz Jundishapur university of medical sciences Esfand Ave, Farvardin Blvd, Ahvaz ahvaz Khouzestan Iran (Islamic Republic of)