Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial
University of Cincinnati
72 participants
Dec 16, 2022
INTERVENTIONAL
Conditions
Summary
This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.
Eligibility
Inclusion Criteria1
- (1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma
Exclusion Criteria3
- persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
- decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and
- (4) pregnancy
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Interventions
Diagnosis of spreading depolarizations in continuous electrocorticography
Protocol for escalation and de-escalation of physiologic-targeted and pharmacologic therapies to treat and prevent spreading depolarizations
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05337618