Effect of an individualized versus standard ...
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Article dans une revue scientifique: Article original
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Title :
Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial.
Author(s) :
Maïer, Benjamin [Auteur]
Fondation Ophtalmologique Adolphe de Rotschild
Gory, Benjamin [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Chabanne, Russell [Auteur]
CHU Gabriel Montpied [Clermont-Ferrand]
Tavernier, Benoit [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Balanca, Baptiste [Auteur]
Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center [CRNL]
Audibert, Gérard [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Thion, Laurie-Anne [Auteur]
Fondation Ophtalmologique Adolphe de Rothschild [Paris]
Le Guen, Morgan [Auteur]
Hôpital Foch [Suresnes]
Geeraerts, Thomas [Auteur]
Université Toulouse III - Paul Sabatier [UT3]
Calviere, Lionel [Auteur]
Département Neurologie [CHU Toulouse]
Degos, Vincent [Auteur]
Maladies neurodéveloppementales et neurovasculaires [NeuroDiderot (UMR_S_1141 / U1141)]
Lapergue, Bertrand [Auteur]
Hôpital Foch [Suresnes]
Richard, Sebastien [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Djarallah, Azeddine [Auteur]
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Mophawe, Ornellia [Auteur]
Fondation Ophtalmologique Adolphe de Rothschild [Paris]
Boursin, Perrine [Auteur]
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Le Cossec, Chloé [Auteur]
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Blanc, Raphael [Auteur]
Fondation Ophtalmologique Adolphe de Rothschild [Paris]
Piotin, Michel [Auteur]
Mazighi, Mikael [Auteur]
Gayat, Etienne [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Fondation Ophtalmologique Adolphe de Rotschild
Gory, Benjamin [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Chabanne, Russell [Auteur]
CHU Gabriel Montpied [Clermont-Ferrand]
Tavernier, Benoit [Auteur]

METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Balanca, Baptiste [Auteur]
Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center [CRNL]
Audibert, Gérard [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Thion, Laurie-Anne [Auteur]
Fondation Ophtalmologique Adolphe de Rothschild [Paris]
Le Guen, Morgan [Auteur]
Hôpital Foch [Suresnes]
Geeraerts, Thomas [Auteur]
Université Toulouse III - Paul Sabatier [UT3]
Calviere, Lionel [Auteur]
Département Neurologie [CHU Toulouse]
Degos, Vincent [Auteur]
Maladies neurodéveloppementales et neurovasculaires [NeuroDiderot (UMR_S_1141 / U1141)]
Lapergue, Bertrand [Auteur]
Hôpital Foch [Suresnes]
Richard, Sebastien [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Djarallah, Azeddine [Auteur]
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Mophawe, Ornellia [Auteur]
Fondation Ophtalmologique Adolphe de Rothschild [Paris]
Boursin, Perrine [Auteur]
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Le Cossec, Chloé [Auteur]
Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
Blanc, Raphael [Auteur]
Fondation Ophtalmologique Adolphe de Rothschild [Paris]
Piotin, Michel [Auteur]
Mazighi, Mikael [Auteur]
Gayat, Etienne [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Journal title :
Trials
Abbreviated title :
Trials
Volume number :
23
Pages :
598
Publication date :
2022-08-01
ISSN :
1745-6215
English keyword(s) :
Stroke
Blood pressure
Thrombectomy
Disability
Mean arterial pressure
Circulation
Randomized controlled trial
Blood pressure
Thrombectomy
Disability
Mean arterial pressure
Circulation
Randomized controlled trial
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
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, ...
Show more >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.Show less >
Show more >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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Submission date :
2023-11-15T03:37:33Z
2024-05-13T12:56:05Z
2024-05-13T12:56:05Z
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