๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Patient with acute cerebral ischemia due to ICA or MCA occlusion
2. Major neurologic deficits: 6โคNIHSSโค20,
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 contraindication to MT, and could be a confounding variable predisposing to intracranial hemorrhage including coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia \<80000/mm3;
5. Second or third-degree heart block without a pacemaker in place,
6. Technical inability to navigate micro-catheter to target clot,
7. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
8. mRS\>2 caused by a history of prior stroke,
9. Severe hepatic dysfunction, severe renal dysfunction (\<30 mL/min), increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
10. Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
11. patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
12. patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
13. patients taking digoxin or other cardiac glycoside