RECRUITINGPhase 2INTERVENTIONAL
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
(1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma
Who Should NOT Join This Trial:
1. persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
2. decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and
(4) pregnancy
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
(1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma
Exclusion Criteria:
1. persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
2. decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and
(4) pregnancy
Treatments Being Tested
DIAGNOSTIC_TEST
Full-band Electrocorticography
Diagnosis of spreading depolarizations in continuous electrocorticography
COMBINATION_PRODUCT
Treatment Algorithm
Protocol for escalation and de-escalation of physiologic-targeted and pharmacologic therapies to treat and prevent spreading depolarizations
Locations (1)
University of Cincinnati
Cincinnati, Ohio, United States