Traumatic Brain Injury Antioxidant Study (Pro-NAC Study)

Protocol Description

The purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury (TBI). TBIs are the leading cause of death and disability among children and young adults. Researchers hope to demonstrate that combinational therapy with a membrane transporter and antioxidant are safe after TBI and can help overcome barriers to the brain, synergistically improving bioavailability and efficacy of the antioxidant content of the body and central nervous system after TBI.

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients of both genders between the ages of 2 to 18 years who have been admitted to the pediatric intensive care unit (PICU) of Children’s Hospital of Pittsburgh of UPMC with severe TBI.
Females: Ages 2 to 18 years
Males: Ages 2 to 18 years

Requirements

Patients will be randomly assigned to receive either a placebo or a combination of probenecid and N-acetyl cysteine (Pro-NAC) via nasogastric or orogastric tube for 3 days. Patients will be monitored for drug safety and to measure antioxidant reserve in serum and cerebral spinal fluid with the presumption that maintaining antioxidant levels within the brain may be neuroprotective.
Visits: Occurs while patient is in the PICU
Duration: PICU length of stay

Status: Open for Enrollment

Source(s) of Support

University of Pittsburgh
National Institutes of Health
National Institute of Neurological Disorders and Stroke

Additional Information

Study Description at National Institutes of Health

Primary Investigator

Robert Clark, MD

Contact Information

For information, please contact:
Michael J. Bell, MD
412-692-5164