Browsing by Author "Brown, Jeremy"

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    Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest
    (Research Square, 2024-06-21) Meurer, William; Schmitzberger, Florian; Yeatts, Sharon; Ramakrishnan, Viswanathan; Abella, Benjamin; Aufderheide, Tom; Barsan, William; Benoit, Justin; Berry, Scott; Black, Joy; Bozeman, Nia; Broglio, Kristine; Brown, Jeremy; Brown, Kimberly; Carlozzi, Noelle; Caveney, Angela; Cho, Sung-Min; Chung-Esaki, Hangyul; Clevenger, Robert; Conwit, Robin; Cooper, Richelle; Crudo, Valentina; Daya, Mohamud; Harney, Deneil; Hsu, Cindy; Johnson, Nicholas J.; Khan, Imad; Khosla, Shaveta; Kline, Peyton; Kratz, Anna; Kudenchuk, Peter; Lewis, Roger J.; Madiyal, Chaitra; Meyer, Sara; Mosier, Jarrod; Mouammar, Marwan; Neth, Matthew; O'Neil, Brian; Paxton, James; Perez, Sofia; Perman, Sarah; Sozener, Cemal; Speers, Mickie; Spiteri, Aimee; Stevenson, Valerie; Sunthankar, Kavita; Tonna, Joseph; Youngquist, Scott; Geocadin, Romergryko; Silbergleit, Robert; Neurology, School of Medicine
    Background: Cardiac arrest is a common and devastating emergency of both the heart and brain. More than 380,000 patients suffer out-of-hospital cardiac arrest annually in the United States. Induced cooling of comatose patients markedly improved neurological and functional outcomes in pivotal randomized clinical trials, but the optimal duration of therapeutic hypothermia has not yet been established. Methods: This study is a multi-center randomized, response-adaptive, duration (dose) finding, comparative effectiveness clinical trial with blinded outcome assessment. We investigate two populations of adult comatose survivors of cardiac arrest to ascertain the shortest duration of cooling that provides the maximum treatment effect. The design is based on a statistical model of response as defined by the primary endpoint, a weighted 90-day mRS (modified Rankin Scale, a measure of neurologic disability), across the treatment arms. Subjects will initially be equally randomized between 12, 24, and 48 hours of therapeutic cooling. After the first 200 subjects have been randomized, additional treatment arms between 12 and 48 hours will be opened and patients will be allocated, within each initial cardiac rhythm type (shockable or non-shockable), by response adaptive randomization. As the trial continues, shorter and longer duration arms may be opened. A maximum sample size of 1800 subjects is proposed. Secondary objectives are to characterize: the overall safety and adverse events associated with duration of cooling, the effect on neuropsychological outcomes, and the effect on patient reported quality of life measures. Discussion: In-vitro and in-vivo studies have shown the neuroprotective effects of therapeutic hypothermia for cardiac arrest. We hypothesize that longer durations of cooling may improve either the proportion of patients that attain a good neurological recovery or may result in better recovery among the proportion already categorized as having a good outcome. If the treatment effect of cooling is increasing across duration, for at least some set of durations, then this provides evidence of the efficacy of cooling itself versus normothermia, even in the absence of a normothermia control arm, confirming previous RCTs for OHCA survivors of shockable rhythms and provides the first prospective controlled evidence of efficacy in those without initial shockable rhythms.
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    Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness
    (Springer, 2022) Mainali, Shraddha; Aiyagari, Venkatesh; Alexander, Sheila; Bodien, Yelena; Boerwinkle, Varina; Boly, Melanie; Brown, Emery; Brown, Jeremy; Claassen, Jan; Edlow, Brian L.; Fink, Ericka L.; Fins, Joseph J.; Foreman, Brandon; Frontera, Jennifer; Geocadin, Romergryko G.; Giacino, Joseph; Gilmore, Emily J.; Gosseries, Olivia; Hammond, Flora; Helbok, Raimund; Hemphill, J. Claude; Hirsch, Karen; Kim, Keri; Laureys, Steven; Lewis, Ariane; Ling, Geoffrey; Livesay, Sarah L.; McCredie, Victoria; McNett, Molly; Menon, David; Molteni, Erika; Olson, DaiWai; O’Phelan, Kristine; Park, Soojin; Polizzotto, Len; Provencio, Jose Javier; Puybasset, Louis; Venkatasubba Rao, Chethan P.; Robertson, Courtney; Rohaut, Benjamin; Rubin, Michael; Sharshar, Tarek; Shutter, Lori; Silva, Gisele Sampaio; Smith, Wade; Steven, Robert D.; Thibaut, Aurore; Vespa, Paul; Wagner, Amy K.; Ziai, Wendy C.; Zink, Elizabeth; Suarez, Jose I.; Physical Medicine and Rehabilitation, School of Medicine
    This proceedings article presents actionable research targets on the basis of the presentations and discussions at the 2nd Curing Coma National Institutes of Health (NIH) symposium held from May 3 to May 5, 2021. Here, we summarize the background, research priorities, panel discussions, and deliverables discussed during the symposium across six major domains related to disorders of consciousness. The six domains include (1) Biology of Coma, (2) Coma Database, (3) Neuroprognostication, (4) Care of Comatose Patients, (5) Early Clinical Trials, and (6) Long-term Recovery. Following the 1st Curing Coma NIH virtual symposium held on September 9 to September 10, 2020, six workgroups, each consisting of field experts in respective domains, were formed and tasked with identifying gaps and developing key priorities and deliverables to advance the mission of the Curing Coma Campaign. The highly interactive and inspiring presentations and panel discussions during the 3-day virtual NIH symposium identified several action items for the Curing Coma Campaign mission, which we summarize in this article.