Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke "HELMET"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Saline Drug
    Other Names: Sodium Chloride
    ARM 1: Kind: Experimental
    Label: Therapeutic hypothermia group
    Description: Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
  • Standard treatment Other
    Intervention Desc: All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines. In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke. Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days. Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Stroke care based on international guidelines
  • Arctic Sun Device
    Other Names: Therapeutic hypothermia
    Intervention Desc: Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered. Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours)
    ARM 1: Kind: Experimental
    Label: Therapeutic hypothermia group
    Description: Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)

Outcomes

Type Measure Time Frame Safety Issue
Primary Favorable outcome 3 months after symptom onset
Primary mortality at 3 months 3 months after symptom onset
Secondary Improvements in neurological functions Volume change on diffusion lesion at 5~7 days
Secondary Symptomatic cerebral hemorrhage within 5~7 days of symptom onset

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