Status:
COMPLETED
Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Acute Cerebrovascular Accident
Eligibility:
All Genders
18+ years
Phase:
NA
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 acu...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2024
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT04352296
Start Date
March 8 2021
End Date
January 16 2024
Last Update
December 16 2024
Active Locations (1)
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1
Hôpital Fondation Adolphe de Rothschild
Paris, France