Acute Cerebrovascular Accident
Conditions
Keywords
Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Blood pressure management, Brain infarction, Endovascular procedure, Thrombectomy, Blood pressure, Low blood pressure, Hemodynamic, Hypertension
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.
Interventions
PROCEDUREIndividualized blood pressure
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
PROCEDUREStandard blood pressure
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).
Sponsors
Ministry of Health, France
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with a favorable functional outcome at 3 months | 3 months visit | Rankin score less than 3 |
Countries
France
Outcome results
None listed