Clinical Trials In Acute Brain Injury

Clinical Trials in Acute Brain Injury

Dr. Hinson has extensive clinical trials experience: leading investigator-initiated observational studies, serving on a clinical trial advisory board and as medical monitor for clinical trials, and as site PI for interventional clinical trials, especially relating to cerebral edema. Cerebral edema contributes to morbidity and mortality after acute brain injuries such as TBI and stroke.

Our group has been involved in modifying the accumulation of malignant edema after large hemispheric stroke through blocking the SUR1-TRPM4 channel in brain endothelium with IV glyburide/glibenclamide.

 

 

 

Relevant publications:

  1. Sheth KN, Albers GW, Saver JL, Campbell BCV, Molyneaux BJ, Hinson HE, Cordonnier C, Steiner T, Toyoda K, Wintermark M, Littauer R, Collins J, Lucas N, Nogueira RG, Simard JM, Wald M, Dawson K, Kimberly WT. Intravenous glibenclamide for cerebral oedema after large hemispheric stroke (CHARM): a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Neurol. 2024 Dec;23(12):1205-1213. doi: 10.1016/S1474-4422(24)00425-3. PubMed PMID: 39577921.
  2. Irvine HJ, Acharjee A, Wolcott Z, Ament Z, Hinson HE, Molyneaux BJ, Simard JM, Sheth KN, Kimberly WT. Hypoxanthine is a pharmacodynamic marker of ischemic brain edema modified by glibenclamide. Cell Rep Med. 2022 Jun 21;3(6):100654. doi: 10.1016/j.xcrm.2022.100654. Epub 2022 Jun 13
  3. Sheth KN, Peterson NH, Cheung K, Elm, JJ, Hinson HE, Molyneaux BJ, Beslow LA, Sze GK, Simard JM, Kimberly WT. Long-term outcomes with IV glyburide from the GAMES-RP study of large hemispheric infarction: an exploratory analysis. Stroke. 2018 May 22. pii: STROKEAHA.117.020365.
  4. Kimberly WT, Bevers MB, von Kummer R, Demchuk AM, Romero JM, Elm JJ, Hinson HE, Molyneaux BJ, Simard JM, Sheth KN. Effect of IV glyburide on adjudicated edema endpoints in the GAMES-RP Trial. Neurology. 2018 Nov 16.
  5. Sheth KN, Elm, JJ, Molyneaux BJ, Hinson HE, Beslow LA, Sze GK, Ostwaldt, del Zoppo GJ, Simard JM, Jacobson S, Kimberly WT. Effect of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomized, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016 Aug 23.