Brain contusion. Focal brain injury
Conditions
Interventions
Intervention 1: Group 1: Oral glibenclamide 10 mg daily for 10 days. Intervention 2: Group 2 : Placebo agent, 10mg Daily, for 10 days.
Treatment - Drugs
Group 1: Oral glibenclamide 10 mg daily for 10 days
Group 2 : Placebo agent, 10mg Daily, for 10 days
Sponsors
Vice Chancellor of Research, Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Documented closed head injury; Age between 18 and 75 years; Having brain contusions on initial brain CT scan; Taking the first dosage of medication within first 10 hours of trauma event; GCS:5-13 without influence of sedations upon admission; Obtaining written informed consent from legally authorized representative Exclusion criteria: Having 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); Spinal cord injury or spinal column instability with neurologic deficit; Penetrating brain injury; Any blood glucose under 50mg/dL or over 500mg/d; Severe renal disorder from past history or Cr>2.5 or patients on hemodialysis; Severe liver disease from past history or total bilirubin above 1.5 times of normal value; INR>1.6; Systolic BP below 90mmHg on admission without respond to fluid resuscitation; Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days; Associated severe non-survivable injury; History of previous brain problems (Tumor, infections, strokes, …); Usage of warfarin, heparin, clopidogrel, LMWH within 72 hours prior to traumatic event
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain contusion and precontusional edema volume. Timepoint: Onadmission, day 3 and 10 after intervention. Method of measurement: CT-volumetry of brain contusions.;Outcome. Timepoint: 6 months after intervention. Method of measurement: Glasgow Outcome Scale (GOS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNima Derakhshan
Shiraz University of Medical Sciences
Outcome results
None listed