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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Fältnamn	Indikatorer	Metadata
000		06534naa a2201333 4500
001		oai:gup.ub.gu.se/335516
003		SwePub
008		240528s2024 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://gup.ub.gu.se/publication/3355162 URI
024	7	a https://doi.org/10.1177/174749302311852752 DOI
040		a (SwePub)gu
041		a eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Poli, Sven4 aut
245	1 0	a Penumbral Rescue by normobaric O?=?O administration in patients with ischemic stroke and target mismatch proFile (PROOF): Study protocol of a phase IIb trial
264	1	c 2024
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Neurovetenskaper0 (SwePub)301052 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Neurosciences0 (SwePub)301052 hsv//eng
653		a Normobaric oxygen therapy
653		a NBO
653		a hyperoxygenation
653		a neuroprotection
653		a penumbra
653		a ischemic stroke
653		a thrombectomy
700	1	a Mbroh, Joshua4 aut
700	1	a Baron, Jean-Claude4 aut
700	1	a Singhal, Aneesh B.4 aut
700	1	a Strbian, Daniel4 aut
700	1	a Molina, Carlos4 aut
700	1	a Lemmens, Robin4 aut
700	1	a Turc, Guillaume4 aut
700	1	a Mikulik, Robert4 aut
700	1	a Michel, Patrik4 aut
700	1	a Tatlisumak, Turgutu Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience4 aut0 (Swepub:gu)xtatlt
700	1	a Audebert, Heinrich J.4 aut
700	1	a Dichgans, Martin4 aut
700	1	a Veltkamp, Roland4 aut
700	1	a Huesing, Johannes4 aut
700	1	a Graessner, Holm4 aut
700	1	a Fiehler, Jens4 aut
700	1	a Montaner, Joan4 aut
700	1	a Adeyemi, Adedolapo Kamaldeen4 aut
700	1	a Althaus, Katharina4 aut
700	1	a Arenillas, Juan F.4 aut
700	1	a Bender, Benjamin4 aut
700	1	a Benedikt, Frank4 aut
700	1	a Broocks, Gabriel4 aut
700	1	a Burghaus, Ina4 aut
700	1	a Cardona, Pere4 aut
700	1	a Deb-Chatterji, Milani4 aut
700	1	a Cvikova, Martina4 aut
700	1	a Defreyne, Luc4 aut
700	1	a De Herdt, Veerle4 aut
700	1	a Detante, Olivier4 aut
700	1	a Ernemann, Ulrike4 aut
700	1	a Flottmann, Fabian4 aut
700	1	a Guillamon, Lidia Garcia4 aut
700	1	a Glauch, Monika4 aut
700	1	a Gomez-Exposito, Alexandra4 aut
700	1	a Gory, Benjamin4 aut
700	1	a Grand, Sylvie Sylvie4 aut
700	1	a Harsany, Michal4 aut
700	1	a Hauser, Till Karsten4 aut
700	1	a Heck, Olivier4 aut
700	1	a Hemelsoet, Dimitri4 aut
700	1	a Hennersdorf, Florian4 aut
700	1	a Hoppe, Julia4 aut
700	1	a Kalmbach, Pia4 aut
700	1	a Kellert, Lars4 aut
700	1	a Kohrmann, Martin4 aut
700	1	a Kowarik, Markus4 aut
700	1	a Lara-Rodriguez, Blanca4 aut
700	1	a Legris, Loic4 aut
700	1	a Lindig, Tobias4 aut
700	1	a Luntz, Steffen4 aut
700	1	a Lusk, Jay4 aut
700	1	a Mac Grory, Brian4 aut
700	1	a Manger, Andreas4 aut
700	1	a Martinez-Majander, Nicolas4 aut
700	1	a Mengel, Annerose4 aut
700	1	a Meyne, Johannes4 aut
700	1	a Muller, Susanne4 aut
700	1	a Mundiyanapurath, Sibu4 aut
700	1	a Naggara, Olivier4 aut
700	1	a Nedeltchev, Krassen4 aut
700	1	a Nguyen, Thanh N.4 aut
700	1	a Nilsson, Maike A.4 aut
700	1	a Obadia, Michael4 aut
700	1	a Poli, Khouloud4 aut
700	1	a Purrucker, Jan C.4 aut
700	1	a Raty, Silja4 aut
700	1	a Richard, Sebastien4 aut
700	1	a Richter, Hardy4 aut
700	1	a Schilte, Clotilde4 aut
700	1	a Schlemm, Eckhard4 aut
700	1	a Stohr, Linda4 aut
700	1	a Stolte, Benjamin4 aut
700	1	a Sykora, Marek4 aut
700	1	a Thomalla, Goetz4 aut
700	1	a Tomppo, Liisa4 aut
700	1	a van Horn, Noel4 aut
700	1	a Zeller, Julia4 aut
700	1	a Ziemann, Ulf4 aut
700	1	a Zuern, Christine S.4 aut
700	1	a Hartig, Florian4 aut
700	1	a Tuennerhoff, Johannes4 aut
710	2	a Göteborgs universitetb Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap4 org
773	0	t INTERNATIONAL JOURNAL OF STROKEg 19:1, s. 120-126q 19:1<120-126x 1747-4930x 1747-4949
856	4 8	u https://gup.ub.gu.se/publication/335516
856	4 8	u https://doi.org/10.1177/17474930231185275

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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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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Basic Medicine; and Neurosciences

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