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Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial
BACKGROUND: Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9317065/ https://www.ncbi.nlm.nih.gov/pubmed/35883180 http://dx.doi.org/10.1186/s13063-022-06538-9 |
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author | Maïer, Benjamin Gory, Benjamin Chabanne, Russell Tavernier, Benoît Balanca, Baptiste Audibert, Gérard Thion, Laurie-Anne Le Guen, Morgan Geeraerts, Thomas Calviere, Lionel Degos, Vincent Lapergue, Bertrand Richard, Sebastien Djarallah, Azeddine Mophawe, Ornellia Boursin, Perrine Le Cossec, Chloé Blanc, Raphael Piotin, Michel Mazighi, Mikael Gayat, Etienne |
author_facet | Maïer, Benjamin Gory, Benjamin Chabanne, Russell Tavernier, Benoît Balanca, Baptiste Audibert, Gérard Thion, Laurie-Anne Le Guen, Morgan Geeraerts, Thomas Calviere, Lionel Degos, Vincent Lapergue, Bertrand Richard, Sebastien Djarallah, Azeddine Mophawe, Ornellia Boursin, Perrine Le Cossec, Chloé Blanc, Raphael Piotin, Michel Mazighi, Mikael Gayat, Etienne |
author_sort | Maïer, Benjamin |
collection | PubMed |
description | BACKGROUND: Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management. METHODS: The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140–180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included. DISCUSSION: DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04352296. Registered on 20th April 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06538-9. |
format | Online Article Text |
id | pubmed-9317065 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-93170652022-07-27 Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial Maïer, Benjamin Gory, Benjamin Chabanne, Russell Tavernier, Benoît Balanca, Baptiste Audibert, Gérard Thion, Laurie-Anne Le Guen, Morgan Geeraerts, Thomas Calviere, Lionel Degos, Vincent Lapergue, Bertrand Richard, Sebastien Djarallah, Azeddine Mophawe, Ornellia Boursin, Perrine Le Cossec, Chloé Blanc, Raphael Piotin, Michel Mazighi, Mikael Gayat, Etienne Trials Study Protocol BACKGROUND: Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management. METHODS: The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140–180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included. DISCUSSION: DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04352296. Registered on 20th April 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06538-9. BioMed Central 2022-07-26 /pmc/articles/PMC9317065/ /pubmed/35883180 http://dx.doi.org/10.1186/s13063-022-06538-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Maïer, Benjamin Gory, Benjamin Chabanne, Russell Tavernier, Benoît Balanca, Baptiste Audibert, Gérard Thion, Laurie-Anne Le Guen, Morgan Geeraerts, Thomas Calviere, Lionel Degos, Vincent Lapergue, Bertrand Richard, Sebastien Djarallah, Azeddine Mophawe, Ornellia Boursin, Perrine Le Cossec, Chloé Blanc, Raphael Piotin, Michel Mazighi, Mikael Gayat, Etienne Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial |
title | Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial |
title_full | Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial |
title_fullStr | Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial |
title_full_unstemmed | Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial |
title_short | Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial |
title_sort | effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the determine randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9317065/ https://www.ncbi.nlm.nih.gov/pubmed/35883180 http://dx.doi.org/10.1186/s13063-022-06538-9 |
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