Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)
ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Cincinnati
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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
Trial design
Treatments tested in this trial
- Full-band Electrocorticography
- Treatment Algorithm
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cincinnati
Lead sponsor
University of New Mexico
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov