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

Phase 3
Conditions
traumatic brain injury.
Diffuse traumatic brain injury
S06.2
Registration Number
IRCT20200815048418N1
Lead Sponsor
Ahvaz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
96
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

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 <50 g/dL or >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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glasgow outcome scale. Timepoint: Three months after TBI. Method of measurement: Glasgow outcome scale.
Secondary Outcome Measures
NameTimeMethod
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