Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ischemic Stroke, Thrombolytic Therapy

Intervention / Treatment
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* Device: Arctic Sun
* Other: Standard treatment
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.) Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal. Patients of both sexes aged between 18 and 80 years old NIHSS scores of 6-25 points at screening mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery) Exclusion Criteria: No evaluation for cranial artery before endovascular treatment Patient with emergent stenting insertion in intracranial or extracranial artery Transient ischemic attack or lacunar infarction Platelet counts < 75,000/mm3 coagulopathy (INR spontaneously >1.5) Hemodynamic instability acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III) Sepsis Pregnant or breastfeeding women Premorbid modified Rankin Scale Scores of > 2 points Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine Intracranial hemorrhage or hemorrhagic transformation in initial CT scan Brain tumor or CNS infection Patients who participated in other clinical trials within 3 months Life expectancy within 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic hypothermia group<br>Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun) | Device: Arctic Sun<br>* 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)<br>* Other names: Therapeutic hypothermia;Drug: Saline<br> <br> |
| Other: Control group<br>Stroke care based on international guidelines | Other: Standard treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable outcome | modified Rankin Scale of 0-2 points at 3 months | 3 months after symptom onset | 
| mortality at 3 months | mortality at 3 months | 3 months after symptom onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in neurological functions | Changes in the cerebral infarction lesions at 5 7 days | Volume change on diffusion lesion at 5 7 days | 
| Symptomatic cerebral hemorrhage | deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image | within 5 7 days of symptom onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic hypothermia