Penumbral Rescue by normobaric O?=?O administration in patients with ischemic stroke and target mismatch proFile (PROOF): Study protocol of a phase IIb trial

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Poli, Sven (author)

Penumbral Rescue by normobaric O?=?O administration in patients with ischemic stroke and target mismatch proFile (PROOF): Study protocol of a phase IIb trial

Article/chapterEnglish2024

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2024

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LIBRIS-ID:oai:gup.ub.gu.se/335516
https://gup.ub.gu.se/publication/335516URI
https://doi.org/10.1177/17474930231185275DOI

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Language:English

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SwePubSwePub

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

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Rationale: Oxygen is essential for cellular energy metabolism. Neurons are particularly vulnerable to hypoxia. Increasing oxygen supply shortly after stroke onset could preserve the ischemic penumbra until revascularization occurs.Aims: PROOF investigates the use of normobaric oxygen (NBO) therapy within 6 h of symptom onset/notice for brain-protective bridging until endovascular revascularization of acute intracranial anterior-circulation occlusion.Methods and design: Randomized (1:1), standard treatment-controlled, open-label, blinded endpoint, multicenter adaptive phase IIb trial.Study outcomes: Primary outcome is ischemic core growth (mL) from baseline to 24 h (intention-to-treat analysis). Secondary efficacy outcomes include change in NIHSS from baseline to 24 h, mRS at 90 days, cognitive and emotional function, and quality of life. Safety outcomes include mortality, intracranial hemorrhage, and respiratory failure. Exploratory analyses of imaging and blood biomarkers will be conducted.Sample size: Using an adaptive design with interim analysis at 80 patients per arm, up to 456 participants (228 per arm) would be needed for 80% power (one-sided alpha 0.05) to detect a mean reduction of ischemic core growth by 6.68 mL, assuming 21.4 mL standard deviation.Discussion: By enrolling endovascular thrombectomy candidates in an early time window, the trial replicates insights from preclinical studies in which NBO showed beneficial effects, namely early initiation of near 100% inspired oxygen during short temporary ischemia. Primary outcome assessment at 24 h on follow-up imaging reduces variability due to withdrawal of care and early clinical confounders such as delayed extubation and aspiration pneumonia.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Medicinska och farmaceutiska grundvetenskaper Neurovetenskaper hsv//swe
MEDICAL AND HEALTH SCIENCES Basic Medicine Neurosciences hsv//eng
Normobaric oxygen therapy
NBO
hyperoxygenation
neuroprotection
penumbra
ischemic stroke
thrombectomy

Added entries (persons, corporate bodies, meetings, titles ...)

Mbroh, Joshua (author)
Baron, Jean-Claude (author)
Singhal, Aneesh B. (author)
Strbian, Daniel (author)
Molina, Carlos (author)
Lemmens, Robin (author)
Turc, Guillaume (author)
Mikulik, Robert (author)
Michel, Patrik (author)
Tatlisumak, TurgutGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience(Swepub:gu)xtatlt (author)
Audebert, Heinrich J. (author)
Dichgans, Martin (author)
Veltkamp, Roland (author)
Huesing, Johannes (author)
Graessner, Holm (author)
Fiehler, Jens (author)
Montaner, Joan (author)
Adeyemi, Adedolapo Kamaldeen (author)
Althaus, Katharina (author)
Arenillas, Juan F. (author)
Bender, Benjamin (author)
Benedikt, Frank (author)
Broocks, Gabriel (author)
Burghaus, Ina (author)
Cardona, Pere (author)
Deb-Chatterji, Milani (author)
Cvikova, Martina (author)
Defreyne, Luc (author)
De Herdt, Veerle (author)
Detante, Olivier (author)
Ernemann, Ulrike (author)
Flottmann, Fabian (author)
Guillamon, Lidia Garcia (author)
Glauch, Monika (author)
Gomez-Exposito, Alexandra (author)
Gory, Benjamin (author)
Grand, Sylvie Sylvie (author)
Harsany, Michal (author)
Hauser, Till Karsten (author)
Heck, Olivier (author)
Hemelsoet, Dimitri (author)
Hennersdorf, Florian (author)
Hoppe, Julia (author)
Kalmbach, Pia (author)
Kellert, Lars (author)
Kohrmann, Martin (author)
Kowarik, Markus (author)
Lara-Rodriguez, Blanca (author)
Legris, Loic (author)
Lindig, Tobias (author)
Luntz, Steffen (author)
Lusk, Jay (author)
Mac Grory, Brian (author)
Manger, Andreas (author)
Martinez-Majander, Nicolas (author)
Mengel, Annerose (author)
Meyne, Johannes (author)
Muller, Susanne (author)
Mundiyanapurath, Sibu (author)
Naggara, Olivier (author)
Nedeltchev, Krassen (author)
Nguyen, Thanh N. (author)
Nilsson, Maike A. (author)
Obadia, Michael (author)
Poli, Khouloud (author)
Purrucker, Jan C. (author)
Raty, Silja (author)
Richard, Sebastien (author)
Richter, Hardy (author)
Schilte, Clotilde (author)
Schlemm, Eckhard (author)
Stohr, Linda (author)
Stolte, Benjamin (author)
Sykora, Marek (author)
Thomalla, Goetz (author)
Tomppo, Liisa (author)
van Horn, Noel (author)
Zeller, Julia (author)
Ziemann, Ulf (author)
Zuern, Christine S. (author)
Hartig, Florian (author)
Tuennerhoff, Johannes (author)
Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap (creator_code:org_t)

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In:INTERNATIONAL JOURNAL OF STROKE19:1, s. 120-1261747-49301747-4949

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By the author/editor: Poli, Sven; Mbroh, Joshua; Baron, Jean-Clau ...; Singhal, Aneesh ...; Strbian, Daniel; Molina, Carlos; show more...; Lemmens, Robin; Turc, Guillaume; Mikulik, Robert; Michel, Patrik; Tatlisumak, Turg ...; Audebert, Heinri ...; Dichgans, Martin; Veltkamp, Roland; Huesing, Johanne ...; Graessner, Holm; Fiehler, Jens; Montaner, Joan; Adeyemi, Adedola ...; Althaus, Kathari ...; Arenillas, Juan ...; Bender, Benjamin; Benedikt, Frank; Broocks, Gabriel; Burghaus, Ina; Cardona, Pere; Deb-Chatterji, M ...; Cvikova, Martina; Defreyne, Luc; De Herdt, Veerle; Detante, Olivier; Ernemann, Ulrike; Flottmann, Fabia ...; Guillamon, Lidia ...; Glauch, Monika; Gomez-Exposito, ...; Gory, Benjamin; Grand, Sylvie Sy ...; Harsany, Michal; Hauser, Till Kar ...; Heck, Olivier; Hemelsoet, Dimit ...; Hennersdorf, Flo ...; Hoppe, Julia; Kalmbach, Pia; Kellert, Lars; Kohrmann, Martin; Kowarik, Markus; Lara-Rodriguez, ...; Legris, Loic; Lindig, Tobias; Luntz, Steffen; Lusk, Jay; Mac Grory, Brian; Manger, Andreas; Martinez-Majande ...; Mengel, Annerose; Meyne, Johannes; Muller, Susanne; Mundiyanapurath, ...; Naggara, Olivier; Nedeltchev, Kras ...; Nguyen, Thanh N.; Nilsson, Maike A ...; Obadia, Michael; Poli, Khouloud; Purrucker, Jan C ...; Raty, Silja; Richard, Sebasti ...; Richter, Hardy; Schilte, Clotild ...; Schlemm, Eckhard; Stohr, Linda; Stolte, Benjamin; Sykora, Marek; Thomalla, Goetz; Tomppo, Liisa; van Horn, Noel; Zeller, Julia; Ziemann, Ulf; Zuern, Christine ...; Hartig, Florian; Tuennerhoff, Joh ...; show less...

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