Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Study Overview
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Brief Summary
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To study safety and feasibility of mild therapeutic hypothermia after decompressive hemicraniectomy compared with hemicraniectomy alone in patients with malignant cerebral infarction

Detailed Description
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The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, single arm, open-label, prospective design. The subject meeting inclusion/exclusion criteria will be assigned to treatment group. The subjects of treatment group should be initiated hypothermia therapy as soon as possible after surgery (less than 6 hours). It can be duration at least 72 hours according to subject status. Also process of recovery temperature period will be allowed within 20-40 hours. After 6 month, 12 month of the onset of symptom, mRS score are measured. This is followed by closure of clinical trial.

Official Title
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Beneficial Effect of Therapeutic Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy Alone in Patients With Malignant Cerebral Infarction (BETHLeHAM Study) - Prospective, Open, Single-arm, Multicenter Phase II Study

Conditions
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Hypothermia

Intervention / Treatment
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* Device: Artic Sun


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Written informed consent obtained from the patient or his/her legally acceptable representative B. Acute ischemic stroke within middle cerebral artery or internal carotid artery occlusion Regardless of anterior cerebral artery (ACA) or posterior cerebral artery (PCA) involvement C. Patients of both sexes aged ≥ 19 years and ≤ 82 years D. NIHSS score ≥ 15 points, NIHSS loss of consciousness 1a score ≥ 1 point E. Patients with proximal cerebral arterial occlusion (such as middle cerebral or internal carotid artery) F. Unilateral ischemic lesion of at least 2/3 of the middle cerebral artery (MCA) territory involving basal ganglia confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) Decided to perform decompressive hemicraniectomy within 48 hours after symptom onset - Onset time was defined as the time when patients were lastly seen normal Exclusion Criteria: A. Premorbid modified Rankin Scale (mRS) score ≥ 2 B. Presence of other type of brain lesions including traumatic brain injury, contralateral or infratentorial infarct. C. Absence of bilateral pupillary reflex D. Known bleeding disorder or coagulopathy E. Sepsis F. End stage malignant disease G. Pregnancy or during breast feeding H. Life expectancy less than 3 year

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 82 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
Intervention Model: Single Group 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) Decompressive Hemicraniectomy care based on international guidelines except therapeutic hypothermia using surface cooling device. | Device: Artic Sun<br>* Induction phase A. Temperature using by esophageal or bladder thermometer. B. Application of a surface cooling device (Arctic Sun) C. Target temperature: 35 ± 0.5 °C D. Induction should be initiated as soon as possible after surgery (less than 6 hours) Maintain phase A. Maintain duration : at least 72 hours and duration can be prolonged according to patient's clinical status B. Use the bedside shivering assessment scale (BSAS) and anti-shivering protocol C. Neuromuscular blocker can be used according to the discretion of the attending physician D. Lung-protective ventilation strategies including low-tidal volume are recommended E. Prophylactic antibiotics can be used to prevent pneumonia during hypothermia Rewarming phase A. Rewarming rate: 0.05 - 0.1 ℃/hr (about 20 - 40 hours) to 37 ℃<br>* Other names: Therapeutic Hypothermia Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rankin Scale | Functional outcome at 1 year modified Rankin Scale of 0 to 4 | 1 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality at 6 month, 1 year | 6 month, 1 year after treatment | 
| Functional outcome | 6 month modified Rankin Scale of 0 to 4 | 6 month after treatment | 

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