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IRCT20170513033941N45 IRCT 2019-01-21 Kashan University of Medical Sciences The effects of oral glibenclamide in patients with traumatic brain injury A clinical trial of effects of oral glibenclamide on size of brain contusions and their peripheral edema in patients with moderate and severe traumatic brain injury 2018-11-06 anticipated 70 Complete https://irct.ir/trial/36786 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to 2 study groups with a 1-to-1 ratio using a computerized random digit generator utilizing the admission number of the patients. Randomization will be done by the use of computer software, Blinding description: Allocation concealment will be done by having procedure indicator cards inside a set of numbered opaque sealed envelopes. Patients will be allocated to treatment groups, after screening. None of the staff or patients will have access to the randomization codes during the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups. 3 Brain contusion. Intervention 1: Intervention group: Oral glibenclamide 15 mg (three tablet, 5 mg each, chemidarou Pharmaceutical Company), daily for 10 days. Intervention 2: Control group: Placebo agent (Barij Essence Pharmaceutical Company, 3 tablets Daily, for 10 days. 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Sajad Yazdani
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 yazdanisajad.hamed@gmail.com Kashan University of Medical Sciences scientific Dr. Esmaeil Fakharian
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 fakharian_e@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients aged between 18 and 75 years with documented closed head injury patients with non-penetrating brain injury Having brain contusions on initial brain CT scan GCS: 5-13 without influence of sedations upon admission Random blood sugar more than 70 mg/dl before the intervention Patients without a lesion on brain CT which urges a surgical evacuation at any time of hospital admission (Surgical EDH, SDH, ICH or midline shift>5mm and decompressive craniectomy) Patients without severe renal disorder from past history or Cr>2.5 Patients without severe liver disease from past history or total bilirubin above 1.5 times of normal value. 18 years 75 years Both Exclusion criteria: Patients with spinal cord injury or spinal column instability with neurologic deficit. Patients with INR>1.6 Systolic BP less than 90 mmHg on admission without respond to fluid resuscitation. Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days Usage of warfarin, heparin, clopidogrel, LMWH within 72 hours prior to traumatic event Usage of glibenclamide 72 hours prior to traumatic event Patients with PaO2<60 mmHg Patients with diabetes mellitus on either oral hypoglycemic agents or insulin before TBI S06.3 Focal traumatic brain injury Treatment - Drugs Placebo Intervention group: Oral glibenclamide 15 mg (three tablet, 5 mg each, chemidarou Pharmaceutical Company), daily for 10 days Control group: Placebo agent (Barij Essence Pharmaceutical Company, 3 tablets Daily, for 10 days Brain contusion volume. Timepoint: On admission, day 3 and 7 days after intervention. Method of measurement: CT-volumetry of brain contusions. Precontusional edema volume. Timepoint: On admission, day 3 and 7 days after intervention. Method of measurement: CT-volumetry of brain contusions. Glasgow Outcome Scale (GOS). Timepoint: On Discharge time and 3 months later. Method of measurement: Physical Examination. Kashan University of Medical Sciences Approved 2018-11-05 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)