Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial.
Blood pressure
Circulation
Disability
Mean arterial pressure
Randomized controlled trial
Stroke
Thrombectomy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
26 Jul 2022
26 Jul 2022
Historique:
received:
21
04
2022
accepted:
11
07
2022
entrez:
26
7
2022
pubmed:
27
7
2022
medline:
29
7
2022
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.
Identifiants
pubmed: 35883180
doi: 10.1186/s13063-022-06538-9
pii: 10.1186/s13063-022-06538-9
pmc: PMC9317065
doi:
Banques de données
ClinicalTrials.gov
['NCT04352296']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
598Subventions
Organisme : French Health Ministry
ID : AOR19069
Investigateurs
Benjamin Maïer
(B)
Simon Escalard
(S)
François Delvoye
(F)
Solène Hebert
(S)
Hocine Redjem
(H)
Stanislas Smajda
(S)
Jean-Philippe Desilles
(JP)
Raphael Blanc
(R)
Michel Piotin
(M)
Mikael Mazighi
(M)
Amélie Yavchitz
(A)
Chloé Le Cossec
(C)
Ornellia Mophawe
(O)
Azedine Djarallah
(A)
Perrine Boursin
(P)
Laurie-Anne Thion
(LA)
Abdenour Amarouche
(A)
Anoushee Shaffii
(A)
Audrey Fogang
(A)
Aurore Marcou
(A)
Elisabeth Ferri
(E)
Fanny Le Garrec
(F)
Ines Da Costa
(I)
Jean-Marie Moures
(JM)
Jean-Michel Devys
(JM)
Malika Omarjee
(M)
Marie-Claude Dubois
(MC)
Marie-Claire Nghe-Mann
(MC)
Matthieu Dorison
(M)
Mélanie Sénéchal
(M)
Pascal Le Bigot
(P)
Nouria Belhadj-Tahar
(N)
Severine Gras
(S)
Simon Clariot
(S)
Stéphane Merat
(S)
Sylvie Froucht-Hirsch
(S)
Yasmine Ait Yahia
(YA)
Pierre Seners
(P)
Candice Sabben
(C)
Bertrand Lapergue
(B)
Morgan Le Guen
(M)
Julien Rousset
(J)
Thomas Geeraerts
(T)
Christophe Cognard
(C)
Jean-Marc Olivot
(JM)
Lionel Calviere
(L)
Maxime Pommier
(M)
Edouard Naboulsi
(E)
Marc Begard
(M)
Camille Boissy
(C)
Thibaud Cammas
(T)
Bernard Cosserant
(B)
Romain Grobost
(R)
Adrien Guyot
(A)
Katia Levrier
(K)
Pierre-Antoine Pioche
(PA)
Ricardo Moreno
(R)
Abderahim Zerroug
(A)
Elie Lteif
(E)
Emmanuel Chabert
(E)
Anna Ferrier
(A)
Aurélie Masgrau
(A)
Baptiste Balanca
(B)
Lionel Bapteste
(L)
Baptiste Bouchier
(B)
Claudio Di Roio
(C)
Charles-Antoine Lak
(CA)
Anisoara Gemanar
(A)
Romain Carrillon
(R)
Carole Bodonian
(C)
Benjamin Gory
(B)
Serge Bracard
(S)
René Anxionnat
(R)
Marc Braun
(M)
Anne-Laure Derelle
(AL)
Liang Liao
(L)
François Zhu
(F)
Emmanuelle Schmitt
(E)
Sophie Planel
(S)
Sébastien Richard
(S)
Lisa Humbertjean
(L)
Gioia Mione
(G)
Jean-Christophe Lacour
(JC)
Marian Douarinou
(M)
Gérard Audibert
(G)
Marcela Voicu
(M)
Lionel Alb
(L)
Marie Reitter
(M)
Madalina Brezeanu
(M)
Agnès Masson
(A)
Adriana Tabarna
(A)
Iona Podar
(I)
Pauline Bourst
(P)
Valérie Georges
(V)
Sarah Guy
(S)
Fatiha Bechiri
(F)
Benoît Tavernier
(B)
Gabriela Julean
(G)
Pierre Boussemart
(P)
Sidi Hamza Roudies
(SH)
Dominique Envain
(D)
Pierre Appourchaux
(P)
Julien Martin
(J)
Victor Lestrade
(V)
Lucie Della Schiava
(LD)
Nicolas Bricout
(N)
Erine Prévost
(E)
Julie Bellet
(J)
Etienne Gayat
(E)
Mikael Mazighi
(M)
Vincent Degos
(V)
Dupont Julie
(D)
Frédéric Clarençon
(F)
Informations de copyright
© 2022. The Author(s).
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