Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
Conditions
Interventions
Intervention1: Glibenclamide: Active agent - glibenclamide administered orally in two divided doses, 96 hours
Control Intervention1: Placebo: Matching placebo administered orally in divided doses, 96
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with documented closed head moderate (Glasgow Coma Scale score between 9-12) to severe TBI (Glasgow Coma Scale score between 4-8) with radiological evidence of brain contusion. 2.Time of injury no more than 12 hours before 3.Written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1.No documented TBI or time of impact not certain 2.Penetrating brain injury 3.Spinal column instability and/or spinal cord injury with neurodeficits 4.Concomitant severe nonsurvivable injury 5.Patients in whom emergent or urgent surgical operation is anticipated that would prevent drug dosing within 12 hours of injury. 6.Blood glucose 7.Severe renal/ liver disorder 8. Systolic BP 10.Hospitalization for brain injury, psychiatric or neurological disease within previous one year. 11. Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical management. 12. Known use of warfarin, clopidogrel, prasugrel, cilostazol, heparin, low molecular weight heparin, heparinoids, or novel oral anticoagulant agents in the previous 72 hours 13.Patients with diabetes mellitus on either oral hypoglycemic agents or insulin before TBI 14.Pregnant, or lactating women. 15.Treatment with another investigational drug within the prior 90 days 16.Allergy to sulfonylurea drugs 17.Known diagnosis of G6PD enzyme deficiency 18.Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in GOS-ETimepoint: Day 90 and 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in GCSTimepoint: From baseline;Change in QOLTimepoint: Day 90 and 180;Days of hospitalization/ ICUTimepoint: Days;Improvement in DRSTimepoint: Day 90 and 180;Improvement in mRSTimepoint: Day 90 and 180;Number of participants requiring decompression craniectomyTimepoint: Day 7;Number of participants with lab confirmed hypoglycemiaTimepoint: Upto Day 7;Participants with contusion expansionTimepoint: Upto 96 hours;Safety AssessmentsTimepoint: Day 180;Time to all cause deathTimepoint: Day 180 | — |
Countries
India
Contacts
Public ContactAshish Kakkar
Postgraduate Institute of Medical Education and Research
Outcome results
None listed