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The primary objective of this study is to estimate the safety of intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-arterial hypothermic magnesium sulfate infusion | Experimental | Patients will receive intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-arterial hypothermic magnesium sulfate infusion | Procedure | According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 330 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 30 ml MgSO4 solution will be infused into the ischemic territory at 15 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 90 days | 90 days after intra-arterial hypothermic magnesium sulfate infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria:
Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal);
During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained;
Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function;
History of allergy to iodinated contrast agents or history of anaphylactic shock;
Baseline blood glucose<50mg/dL (2.78mmol) or>400mg/dL (22.20mmol);
*Acceptable fingertip blood glucose results
Baseline platelet count<50 × 10^9/L;
Recently (i.e. within 30 days prior to inclusion in the study), there has been a history of significant gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal coagulation factors, or bleeding tendency (taking anticoagulant drugs with INR ≥ 3 or PT ≥ 3 × ULN; if the researcher believes that the subject has no coagulation dysfunction, there is no need to wait for coagulation test results to determine whether to enroll);
During a stroke, there may be fever or active infections that require systemic treatment (such as active pulmonary tuberculosis);
History of chronic heart failure with NYHA criteria>1; Uncontrolled hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>105mmHg after standardized treatment), hypotension (systolic blood pressure ≤ 100mmHg after standardized treatment), unstable angina, myocardial infarction, or bypass or stent surgery within 6 months;
Accompanied by pulmonary diseases such as chronic obstructive pulmonary disease, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, irregular breathing, etc;
Severe liver and kidney dysfunction, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr<25ml/min), hepatorenal syndrome, etc;
Pregnant or lactating women;
Patients with acute stroke within 48 hours after percutaneous cardiovascular and cerebrovascular intervention and major surgery;
Currently participating in interventional clinical trials and using research drugs or medical devices;
Participants may not be able to complete this study due to other reasons or may not be considered eligible for inclusion by the researchers;
Image exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD, PhD | Contact | 010-83198952 | jixm@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| Endovascular thrombectomy | Procedure | All patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion. |
|
| Intravenous thrombolysis | Drug | All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion |
|
| All Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion |
| All Treatment Emergent Adverse Event (TEAE) occurring during treatment period | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion |
| The proportion of symptomatic/asymptomatic intracranial hemorrhage within 24 h | Within 24 hours after intra-arterial hypothermic magnesium sulfate infusion |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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