In a proactive response to the growing issue of traumatic brain injuries (TBI), the University of Cincinnati has announced its participation in a nationwide clinical trial. This initiative aims to evaluate the efficacy of three FDA-approved medications in enhancing recovery outcomes for TBI patients.
As reported by the university, the Centers for Disease Control and Prevention (CDC) estimates that TBIs result in over 586 hospitalizations and around 190 fatalities each day in the United States, underscoring the urgent need for innovative treatment solutions. Leading the trial at the university is Dr. Laura Ngwenya, a recognized expert in the field. “These are drugs that are currently FDA-approved and used for different indications,” she stated in the university”s announcement.
The medications under investigation include atorvastatin calcium, minocycline hydrochloride, and candesartan cilexetil. These drugs are being repurposed in this trial to assess their potential in improving recovery from TBIs. The study employs an adaptive trial design, allowing for real-time adjustments to protocols based on the performance of the medications.
Recovery from a TBI is a complex process, often requiring extensive follow-up that includes blood tests, imaging, and various assessments over a six-month period. This trial will also investigate biomarkers, which are expected to not only monitor recovery but also assist in determining eligibility for the study, as indicated in statements from the university. The research team aims to establish connections between these biomarkers and patient recovery, potentially paving the way for more personalized treatment approaches.
The University of Cincinnati plans to enroll approximately 35 to 40 participants in this trial, which is part of a broader study involving 18 sites with a target enrollment of about 672 patients. “Because the drugs selected for the study are already FDA-approved, successful completion of this trial will allow immediate use in clinical practice to improve outcomes for patients with TBI,” Ngwenya expressed, highlighting the potential for rapid implementation of findings.
As a hub of innovation, the University of Cincinnati is committed to advancing research in this critical area. Interested individuals seeking more information about this vital medical study can contact the university at 513-475-8001. The trial is sponsored by the TRACK-TBI Network, affiliated with the University of California, San Francisco, which brings a wealth of expertise and resources to the various sites involved in this important research.
As the trial progresses, its outcomes could represent a significant advancement in the clinical management of TBI, addressing the widespread impact of these injuries on individuals and society.
