Baylor College of Medicine
The goal of this Phase I unblinded, dose-escalation trial is to evaluate the safety and tolerability of intra-arterial magnesium sulfate injection after mechanical thrombectomy in patients experiencing acute ischemic stroke. This trial is one of the first trials to look at IA administration of magnesium sulfate into at risk brain tissue in a selective and localized fashion.
Patients meeting inclusion and exclusion criteria will undergo a baseline neurologic assessment and will be enrolled following informed consent. The patient will then be taken to the Interventional Radiology suite where the patient will undergo MT as per the standard of care. Participation in this study will never delay the timely provision of urgent MT to patients. Additionally, as part of the study procedure, the patient will be assigned to Treatment Group 1,2, 3 or 4 based on the consecutive sampling scheme. The first 6 patients enrolled will be in group 1 and receive the lowest dose of Mg…
Inclusion Criteria: 1. Patient with acute cerebral ischemia due to ICA or MCA occlusion 2. Major neurologic deficits: 6≤NIHSS≤20, 3. Premorbid mRS 0 or 1, or 2 4. Patient's clinical attending physician plans MT procedure as part of routine clinical care, 5. undergo MT with a TICI 2a or better recanalization, 6. Signed informed consent. Exclusion Criteria: 1. Positive pregnancy test; 2. those undergoing MT with a TICI \<2a revascularization; 3. tandem occlusion of the cervical common or internal carotid artery; and 4. subjects on therapeutic anticoagulation, as it is a relative contraindicat…
Following MT and IA injection of MgSO4, patients will also receive a continuous infusion of 16g MgSO4 diluted in 240 ml of 0.9% normal saline, infusing at a rate of 10 ml per hour for 24 hours.
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