Clinical trial NCT04352296: Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke
Official title: Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cerebrovascular Accident
Keywords: Acute ischemic stroke
Large vessel occlusion
Mechanical thrombectomy
Blood pressure management
Brain infarction
Endovascular procedure
Thrombectomy
Blood pressure
Low blood pressure
Hemodynamic
Hypertension
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Ministry of Health, France
First posted: 2020-04-20
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

Detailed description: This study have to objective to evaluate the efficacy of an individualized BP control during mechanical thrombectomy (regardless of the sedation modality), by maintaining a mean arterial pressure (MAP) within 10% of the first MAP measured in the angiography suit, compared to the standard BP management, on the 3-month functional outcome.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* Acute ischemic stroke due to an anterior large vessel occlusion: occlusion of the M1 or M2 segments of the middle cerebral artery, anterior cerebral artery (A1 segment), intracranial internal carotid artery, or tandem occlusions.
* Indication for mechanical thrombectomy under general anesthesia or conscious sedation within the first 6 hours from symptoms onset or within the first 24 hours if DAWN or DEFUSE-3 criteria are met.
* Affiliation to social security assurance.

Exclusion Criteria:

* Contre-indication to mechanical thrombectomy
* Intubation or induction of general anaesthesia prior to randomization
* Acute ischemic strokes associated with a posterior circulation large vessel occlusion (basilar artery, vertebral artery, posterior cerebral artery)
* Intra-hospital onset of acute ischemic stroke, or secondary to a medical, interventional or surgical procedure (interventional cardiology, cardiac or vascular surgery) or any post-surgery ischemic stroke.
* Pre-existing neurological disability limiting neurological assessment at 3 months: mRS \>2 at randomization.
* Contraindication to iodinated contrast agents
* Known pregnancy or breastfeeding woman

Primary outcomes:
measure: Number of patient with a favorable functional outcome at 3 months
timeFrame: 3 months visit
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
Study officials:
affiliation: Hopital Fondation A de Rothschild
name: Benjamin Dr Maier
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Lariboisière, AP-HP
name: Etienne Dr Gayat
role: STUDY_CHAIR
affiliation: Hôpital Foch
name: Morgan Dr Leguen
role: STUDY_CHAIR
affiliation: CHU Gabriel Montpied
name: Russel Dr Chabanne
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon, Hôpital Pierre Wertheimer
name: Baptiste Dr Balanca
role: STUDY_CHAIR
affiliation: Hôpital Roger Salengro, Lille
name: Benoit Pr Tavernier
role: STUDY_CHAIR
affiliation: Hôpital Purpan, CHU Toulouse
name: Thomas Pr Geeraerts
role: STUDY_CHAIR
affiliation: "Centre Hospitalier Régional Universitaire (Nancy)
name: Benjamin Pr Gory
role: STUDY_CHAIR
affiliation: Centre Hospitalier Régional Universitaire de Tours
name: Grégoire Dr Boulouis
role: STUDY_CHAIR
affiliation: La Pitié Salpêtrière (APHP)
name: Vincent Pr Degos
role: STUDY_CHAIR
affiliation: CHU de Bordeaux, Hôpital Pellegrin
name: Gaultier Dr Marnat
role: STUDY_CHAIR
References:
citation: Maier B, Gory B, Chabanne R, Tavernier B, Balanca B, Audibert G, Thion LA, Le Guen M, Geeraerts T, Calviere L, Degos V, Lapergue B, Richard S, Djarallah A, Mophawe O, Boursin P, Le Cossec C, Blanc R, Piotin M, Mazighi M, Gayat E; DETERMINE Investigators. Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial. Trials. 2022 Jul 26;23(1):598. doi: 10.1186/s13063-022-06538-9.