WSO - January 2024 - 120

1185275
WSO
International Journal of StrokePoli et al.
Protocol
Penumbral Rescue by normobaric O = O
administration in patients with ischemic
stroke and target mismatch proFile
(PROOF): Study protocol of a phase
IIb trial
Sven Poli1,2 , Joshua Mbroh1, Jean-Claude Baron3,
Aneesh B Singhal4, Daniel Strbian5, Carlos Molina6,
Robin Lemmens7,8, Guillaume Turc3,9 , Robert Mikulik10,
Patrik Michel11 , Turgut Tatlisumak5,12,13, Heinrich J Audebert14
Martin Dichgans15,16,17,18, Roland Veltkamp19,20,
Johannes Hüsing21,22, Holm Graessner23, Jens Fiehler24,25,
Joan Montaner26, Adedolapo Kamaldeen Adeyemi1,
Katharina Althaus28 , Juan F Arenillas29 , Benjamin Bender30
International Journal of Stroke
2024, Vol. 19(1) 120 -126
© 2023 World Stroke Organization
Article reuse guidelines:
sagepub.com/journals-permissions
DOI: 10.1177/17474930231185275
journals.sagepub.com/home/wso
https://doi.org/10.1177/17474930231185275
,
,
Frank Benedikt31, Gabriel Broocks32 , Ina Burghaus21,
Pere Cardona33, Milani Deb-Chatterji34, Martina Cviková35,
Luc Defreyne36, Veerle De Herdt37, Olivier Detante38,39,
Ulrike Ernemann30, Fabian Flottmann32 , Lídia García Guillamón26,
Monika Glauch23, Alexandra Gomez-Exposito1, Benjamin Gory41,
Sylvie Sylvie Grand39,42, Michal Haršány35,43,
Till Karsten Hauser30, Olivier Heck42, Dimitri Hemelsoet37,
Florian Hennersdorf30, Julia Hoppe34, Pia Kalmbach1,
Lars Kellert44, Martin Köhrmann31, Markus Kowarik1,2,
Blanca Lara-Rodríguez33, Loic Legris38,39 , Tobias Lindig30,
Steffen Luntz21, Jay Lusk45, Brian Mac Grory45,46,47, Andreas Manger27,
Nicolas Martinez-Majander5, Annerose Mengel1, Johannes Meyne48,
Susanne Müller28, Sibu Mundiyanapurath49, Olivier Naggara50,
Krassen Nedeltchev51, Thanh N Nguyen52,53 , Maike A Nilsson21,
Michael Obadia54, Khouloud Poli1, Jan C Purrucker49, Silja Räty5
,
Sebastien Richard55, Hardy Richter56, Clotilde Schilte57,
Eckhard Schlemm58 , Linda Stöhr59, Benjamin Stolte31,
Marek Sykora60, Götz Thomalla34, Liisa Tomppo5, Noel van Horn32
,
Julia Zeller1, Ulf Ziemann1,2, Christine S Zuern61, Florian Härtig27*
and Johannes Tuennerhoff1,2* on behalf of the PROOF investigators
Abstract
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 brainprotective
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.
Correction (September 2023): Article updated to correct author affiliations; for further details please see the
Article Note at the end of the article.
International Journal of Stroke, 19(1)
https://www.doi.org/10.1177/17474930231185275 http://www.sagepub.com/journals-permissions http://journals.sagepub.com/home/wso
WSO - January 2024

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