Single Source: NINDS Exploratory Clinical Trials (U01 Clinical Trial Required)

Background
The National Institute of Neurological Disorders and Stroke (NINDS) is announcing its intent to issue a single source cooperative agreement (U01) award to the Hennepin Healthcare Research Institute to renew and extend funding of the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial. HOBIT is a Phase II clinical trial designed to identify the most effective and safe hyperoxia treatment schedule and to provide evidence whether further study of the potential benefits of HBO as a treatment in patients with severe traumatic brain injury is warranted.

Grant Details
Activities included under this award are: Continue to enroll and complete randomization of eligible participants into the clinical trial, conduct additional interim analyses as planned, continue and complete follow-up of all enrolled patients to their primary endpoint, close-out of study sites and all clinical trial activities, analyze and report the study outcomes, including publication, submitting results to clinicaltrials.gov, and public sharing of the final dataset.

Eligibility Requirements
Only the Hennepin Healthcare Research Institute is eligible for this single source funding. Foreign organizations are not eligible to apply. The PI/PDs associated with the award issued under PAR-13-281 to Hennepin Healthcare Research Institute are eligible to apply for this single source funding.

Period of Performance
The maximum project period is 5 years.

Grant Value
NINDS expects to commit a maximum of $2 million total costs per year by funding one award, contingent upon NIH appropriations and the submission of a meritorious application. Application budgets are limited to $2 million total costs per year to support all activities needed to complete the current clinical trial.