Role of Sulphonylurea-receptor1(SUR1) inhibition in Traumatic Brain injury (TBI): A randomized controlled trial to assess efficacy and safety of Glibenclamide in moderate to severe TBI - STRATEGY

ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•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

发起方

ICMR