Hyperbaric Oxygen Brain Injury Treatment Trial

Summary

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Timeline

Start

2018-06-25

Primary completion

2028-10-26

Completion

2029-06-30

Publications

• Background Rockswold SB, Rockswold GL, Zaun DA, Zhang X, Cerra CE, Bergman TA, Liu J. A prospective, randomized clinical trial to compare the effect of hyperbaric to normobaric hyperoxia on cerebral metabolism, intracranial pressure, and oxygen toxicity in severe traumatic brain injury. J Neurosurg. 2010 May;112(5):1080-94. doi: 10.3171/2009.7.JNS09363.
• Background Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
• Results Rahman MM, Saif MSI, Beall J, Martin RL, Rockswold GL, Barsan WG, Korley FK, Silbergleit R, Stevenson V, Gajewski B. A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury. Contemp Clin Trials Commun. 2025 Dec 5;48:101586. doi: 10.1016/j.conctc.2025.101586. eCollection 2025 Dec.
• Results Bantis LE, Young KJ, Tsimikas JV, Mosier BR, Gajewski B, Yeatts S, Martin RL, Barsan W, Silbergleit R, Rockswold G, Korley FK. Statistical assessment of the prognostic and the predictive value of biomarkers-A biomarker assessment framework with applications to traumatic brain injury biomarker studies. Res Methods Med Health Sci. 2023 Jan;4(1):34-48. doi: 10.1177/26320843221141056. Epub 2022 Dec 13.
• Results Wang Y, Yeatts SD, Martin RH, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Rockswold S, Gajewski BJ. Selection of a statistical analysis method for the Glasgow Outcome Scale-Extended endpoint for estimating the probability of favorable outcome in future severe TBI clinical trials. Stat Med. 2023 Nov 10;42(25):4582-4601. doi: 10.1002/sim.9877. Epub 2023 Aug 20.
• Results Beall J, Yeatts SD, Silbergleit R, Shutter L, Korley F, Gajewski B. Bayesian enrollment modeling for several emergency medicine clinical trials. Trials. 2025 Nov 10;26(1):483. doi: 10.1186/s13063-025-08748-3.
• Results Shi X, Wick JA, Martin RL, Beall J, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Rockswold S, Gajewski BJ. Improved mortality analysis in early-phase dose-ranging clinical trials for emergency medical diseases using Bayesian time-to-event models with active comparators. Stat Med. 2024 Aug 30;43(19):3649-3663. doi: 10.1002/sim.10141. Epub 2024 Jun 17.
• Results Yeatts SD, Martin RH, Meurer W, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Wright DW, Gajewski BJ. Sliding Scoring of the Glasgow Outcome Scale-Extended as Primary Outcome in Traumatic Brain Injury Trials. J Neurotrauma. 2020 Dec 15;37(24):2674-2679. doi: 10.1089/neu.2019.6969. Epub 2020 Aug 26.
• Results Gajewski BJ, Meinzer C, Berry SM, Rockswold GL, Barsan WG, Korley FK, Martin RH. Bayesian hierarchical EMAX model for dose-response in early phase efficacy clinical trials. Stat Med. 2019 Jul 30;38(17):3123-3138. doi: 10.1002/sim.8167. Epub 2019 May 9.
• Results Gajewski BJ, Berry SM, Barsan WG, Silbergleit R, Meurer WJ, Martin R, Rockswold GL. Hyperbaric oxygen brain injury treatment (HOBIT) trial: a multifactor design with response adaptive randomization and longitudinal modeling. Pharm Stat. 2016 Sep;15(5):396-404. doi: 10.1002/pst.1755. Epub 2016 Jun 15.

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