Overcoming Membrane Transporters to Improve CNS Drug Delivery - Improving Brain Antioxidants After Traumatic Brain Injury

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury. Traumatic brain injuries are the leading cause of death and disability among children and young adults.

Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after TBI and can overcome barriers to the brain and synergistically improve bioavailability and efficacy the antioxidant content of the body and CNS after TBI.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH)
• Treatments: Acetylcysteine; N-monoacetylcystine; Probenecid

Criteria

Inclusion Criteria:

• Children (age 2 - 18 y) with severe TBI (GCS < or = 8) with an externalized ventricular drain placed for measurement of intracranial pressure

Exclusion Criteria:

1. Brain dead on admission to ICU

2. Pregnancy

3. Contraindications to enteral medications

4. Contraindications to probenecid:

• status epilepticus

• blood dyscrasias

• under 2 years-of-age

• coadministration of salicylates

• renal dysfunction or urate kidney stones

• hypersensitivity to probenecid

5. Contraindications to N-acetylcysteine: hypersensitivity to N-acetylcysteine

6. Family unwilling to consent