The effects of oral glibenclamide in patients with traumatic brain injury

Phase 3

Conditions: Focal traumatic brain injury
Brain contusion.

Registration Number: IRCT20170513033941N45

Lead Sponsor: Kashan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 70

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.

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain contusion volume. Timepoint: On admission, day 3 and 7 days after intervention. Method of measurement: CT-volumetry of brain contusions.

Secondary Outcome Measures

Name	Time	Method
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.