Role of glibenclamide in head injury
- Conditions
- Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
- Registration Number
- CTRI/2023/12/060716
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <70mg/dL
7.Severe renal/ liver disorder
8. Systolic BP <90 mm Hg and not responsive to fluid resuscitation
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method