Status:
RECRUITING
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
University of New Mexico
University of Pennsylvania
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 o...
Detailed Description
The goal of acute TBI treatment is to minimize secondary damage that evolves over hours to days after the primary injury. Until now, however, there have been no methods for monitoring heterogeneous pa...
Eligibility Criteria
Inclusion
- (1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma
Exclusion
- 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
Key Trial Info
Start Date :
December 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05337618
Start Date
December 16 2022
End Date
March 20 2027
Last Update
December 22 2025
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267