Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke

Fondation Ophtalmologique Adolphe de Rothschild433 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

433

Conditions

Acute Cerebrovascular Accident

Interventions

Individualized blood pressurePROCEDURE

Individualized blood pressure management during mechanical thrombectomy with the administration of diluted norepinephrine (5-10 µg/ml) or nicardipine (1 mg/ml) or urpidil (5 mg/ml) to maintain the MAP within 10% of the first MAP measured in the angiography suit

Standard blood pressurePROCEDURE

Standard blood pressure management based on international guidelines: Treatment of hypotension defined by a systolic blood pressure \<140 mm Hg, and treatment of hypertension defined by a systolic blood pressure \> 180 mm Hg or diastolic blood pressure \>105 mm Hg) with usual treatments (norepinephrine, ephedrine or phenylephrine for hypotension; intravenous nicardipine or uradipil for hypertension).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Fondation Adolphe de Rothschild

Paris, France

Outcomes

Primary Outcomes

Number of patient with a favorable functional outcome at 3 months

Rankin score less than 3

Time frame: 3 months visit

Data from ClinicalTrials.gov

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