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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Acute Cerebrovascular Accident

Treatments: Procedure: Standard blood pressure; Procedure: Individualized blood pressure

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04352296

BMR_2020_12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 433 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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433 participants in 2 patient groups

Experimental group

Experimental group

Description:

Individualized BP 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.

Treatment:

Procedure: Individualized blood pressure

Control group

Active Comparator group

Description:

Standard BP 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).

Treatment:

Procedure: Standard blood pressure