Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial.
[en] [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, 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.
Disciplines :
Neurology
Author, co-author :
Maïer, Benjamin ; Interventional Neuroradiology Department, Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France. bmaier@for.paris ; Université Paris-Cité, Paris, France. bmaier@for.paris
Gory, Benjamin; Diagnostic and Therapeutic Neuroradiology Department, CHRU-Nancy, Université de Lorraine, INSERM U124, Nancy, France
Chabanne, Russell; Department of Anesthesia, Critical Care and Peri-Operative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
Tavernier, Benoît; Department of Anesthesia and Critical Care, University Hospital, Lille, F-59000, Lille, France ; Université Lille, ULR 2694 - METRICS, F-59000, Lille, France
Balanca, Baptiste; Department of Neurological Anesthesiology and Intensive Care, Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Groupement Hospitalier Est, 59 Boulevard Pinel, 69500, Bron, Lyon, France ; Lyon's Neuroscience Research Center, INSERM U1028/CNRS UMR 5292, Lyon 1 University, Lyon, France
Audibert, Gérard; Anesthesiology Department, CHRU Nancy, Nancy, France
Thion, Laurie-Anne; Anesthesiology Department, Hôpital fondation A. de Rothschild, Paris, France
Le Guen, Morgan; Anesthesiology Department, Foch Hospital, Suresnes, France
Geeraerts, Thomas; Anesthesiology and Critical Care department, University Hospital of Toulouse, University Toulouse 3-Paul Sabatier, Toulouse, France
Calviere, Lionel; Neurology Department, University Hospital of Toulouse, Toulouse, France
Degos, Vincent; Department of Anesthesia, Critical Care and Peri-Operative Medicine, APHP, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France ; INSERM UMR 1141, Paris, France
Lapergue, Bertrand; Neurology Department, Stroke Unit, Foch Hospital, Suresnes, France
Richard, Sebastien; Neurology Department, CHRU-Nancy, Université de Lorraine, Nancy, France
Djarallah, Azeddine; Clinical Research Unit, Hôpital fondation A. de Rothschild, Paris, France
Mophawe, Ornellia; Clinical Research Unit, Hôpital fondation A. de Rothschild, Paris, France
Boursin, Perrine; Interventional Neuroradiology Department, Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France
Le Cossec, Chloé; Clinical Research Unit, Hôpital fondation A. de Rothschild, Paris, France
Blanc, Raphael; Interventional Neuroradiology Department, Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France
Piotin, Michel; Interventional Neuroradiology Department, Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France
Mazighi, Mikael; Interventional Neuroradiology Department, Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France ; Université Paris-Cité, Paris, France
Gayat, Etienne; Université Paris-Cité, Paris, France ; Anesthesiology Department, Hôpital Lariboisière, Paris, France
Delvoye, François ; Université de Liège - ULiège > Département des sciences cliniques
Language :
English
Title :
Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial.
We acknowledge the support of the “Unité de Recherche Clinique,” “Centre de Recherche et Formation en Pathologie Neurovasculaire.” We also thank Gabriel and Luis Chiche for the design of the logo. Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France.DETERMINE is an academic RCT, funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique Inter-Régional 2019). The study was designed and will be conducted, analyzed, interpreted, and written independently of the funder.DETERMINE is an academic, multicenter, prospective, randomized, open-label, with blinded endpoint assessment clinical trial (PROBE) (Fig. ). This trial, funded by the French Health Ministry, sponsored by the Hôpital Fondation A. de Rothschild, is currently conducted in 9 comprehensive stroke centers in France. The first patient was included in March 2021.
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