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Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke — HELMET  

Ischemic Stroke Clinical Trial

Official title:
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study

Clinical Trial Summary

To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.

Clinical Trial Description

The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02985060
Study type Interventional
Source Seoul National University Hospital
Contact MOON-KU HAN, professor
Phone 82-31-787-7464
Email mkhan@snu.ac.kr
Status Recruiting
Phase Phase 2
Start date November 2016
Completion date November 2017
View Details
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