Phase
Condition
Stroke
Cerebral Ischemia
Hemorrhage
Treatment
Phenobarbital Sodium Injection
Levetiracetam
Valproate Sodium
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Currently ICU hospitalized.
Suppression of consciousness related to a neurological injury by medical chartreview.
Glasgow Coma Scale of less than 13 at enrollment by medical chart review.
Diagnosis of Acute brain injury by TBI, hypoxic-ischemic insult, cardiac arrest, orstroke by medical chart review.
2 to 90 days from acute brain injury to enrollment time by medical chart review.
Have a surface EEG performed after the current ICU admission
Clinically stable to undergo MRI scan, This stability is defined by care teamconcept, which should be stated in the medical records.
Exclusion
Exclusion Criteria:
Previous medical history of Epilepsy by medical chart review.
Previous medical history of neurological sequels that lead to dependence on care forbasic daily activities, by Barthel index score less than 80.
Known allergy/Hypersensitivity or medical contraindications (like porphyria orcardiac arrhythmias) to the treatment protocol options, leaving no potentialcombination of drugs for the intervention without concerns for adverse eventsrelated to known preexistent conditions.
Considered with Brain death by the care team in the medical record, at any time.
Speaking fluently or at their prior reported baseline mental status by medical chartreview before the intervention starts.
Contraindications for MRI scan.
Prisoner human subjects by medical chart review.
Confirmed currently pregnant by medical history or by positive blood or urinepregnancy test done in the present hospital admission.
Treating physician determines the patient is no candidate to receive 2 of the 5protocol-specified ASM.
Study Design
Connect with a study center
UNC Health
Chapel Hill, North Carolina 27599
United StatesSite Not Available
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