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Evaluation of the effect of glibenclamide in patients with traumatic diffuse brain injuries

Evaluation of the effect of glibenclamide on improving the treatment results and consciousness of patients with traumatic brain diffuse axonal injury

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200815048418N1
Enrollment
96
Registered
2020-12-12
Start date
2019-02-18
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

traumatic brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: daily 10 mg glibenclamide for 10 days. Intervention 2: Control group: placebo Prescription.

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All TBI patients with moderate(9-12)to severe(4-8) GCS referred to the emergency department of Golestan Hospital in Ahvaz with a maximum of 24 hours after TBI.

Exclusion criteria

Exclusion criteria: Patients with diabetes mellitus, patients that required surgery, spinal cord injury, patients with any known history of renal or hepatic diseases, patients with past medical history of brain tumors, blood glucose 500 mg/dL on admission; internal organs diseases, penetrating brain injury, creatinine >2.5mg/dL or on hemodialysis, total bilirubin >1.5 times of normal value, infections, or previous craniotomy; pregnant patients or patients who intended to breastfeed after being discharged; patients with international normalized ratio >1.5 or use of antiplatelets or anti coagulants within 7 days before admission, history of glucose-6-phosphate dehydrogenase deficiency or any diagnosed allergy to sulfonylurea; patients with contusions in brainstem or an systolic blood pressure <90 mm Hg without response to fluid resuscitation; and patients with contraindications to oral route for taking the medication or treatment with other investigational agents during hospitalization.

Design outcomes

Primary

MeasureTime frame
Glasgow outcome scale. Timepoint: Three months after TBI. Method of measurement: Glasgow outcome scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHesam Rasoulian

Ahvaz University of Medical Sciences

hr9473.hr@gmail.com009833114155

Outcome results

None listed

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