NCT06760195

Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke

Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke: a Safety Study

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	Intra-arterial hypothermic magnesium sulfate infusion	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.
PROCEDURE	Endovascular thrombectomy	All patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion.
DRUG	Intravenous thrombolysis	All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-01-06
• Last updated: 2025-01-07

Locations

1 site across 1 country: China