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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N45

Enrollment

Registered

2019-01-21

Start date

2018-11-06

Completion date

Unknown

Last updated

2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain contusion. Focal traumatic brain injury

Interventions

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 Essenc

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sajad Yazdani

Kashan University of Medical Sciences

yazdanisajad.hamed@gmail.com+98 31 4446 0180

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026