Effects of oral glibenclamide in patients with traumatic brain injury

Phase 3

• Conditions: Brain contusion.; Focal brain injury

• Registration Number: IRCT2014121720353N1
• Lead Sponsor: Vice Chancellor of Research, Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 104

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).