Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke
- Conditions
- Acute Cerebrovascular Accident
- Interventions
- Procedure: Individualized blood pressureProcedure: Standard blood pressure
- Registration Number
- NCT04352296
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 433
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Individualized blood pressure 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. Control group Standard blood pressure 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).
- Primary Outcome Measures
Name Time Method Number of patient with a favorable functional outcome at 3 months 3 months visit Rankin score less than 3
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital Fondation Adolphe de Rothschild
🇫🇷Paris, France