The primary objective of this study is to estimate the safety and effectiveness of selective intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 350 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 50 ml MgSO4 solution will be infused into the ischemic territory at 10 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min.
According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 500 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 50 ml MgSO4 solution will be infused into the ischemic territory at 10 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min. Then pause for 5 min, followed by another 5 min of infusion at the original rate.
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Mortality at 90 days
Time frame: 90 days after intra-arterial hypothermic magnesium sulfate infusion
Effectiveness evaluation indicators:
Percentage of subjects with 90 days of functional independence (defined as mRS 0-2) (%) Evaluation time: 90 d (±14 d) after surgery
Time frame: 90 days after intra-arterial hypothermic magnesium sulfate infusion
Grade 3-5 Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period
TEAE includes but not limited to cardiovascular system response, abnormal electrocardiogram, water-electrolyte imbalance, core temperature decreasing, vascular spasm, shiver, infect, disturbance of consciousness.
Time frame: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
All Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period
Time frame: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
All Treatment Emergent Adverse Event (TEAE) occurring during treatment period
Time frame: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
The proportion of symptomatic/asymptomatic intracranial hemorrhage within 24 hours
Time frame: Within 24 hours after intra-arterial hypothermic magnesium sulfate infusion
No reflux rate
No reflux rate, defined as the percentage of subjects with a decrease in CBV or CBF by more than 15% compared to the contralateral side at 24 hours after treatment (%)
Time frame: 24 hours (±6 hours) after surgery
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According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 650 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 50 ml MgSO4 solution will be infused into the ischemic territory at 10 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min. Then pause for 5 min, followed by intermittent infusion at the original rate for another 5 min twice. The interval between two times is also 5 min.