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| Name | Class |
|---|---|
| Bard Medical Division C.R. Bard Inc | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Hypothermia Group | Experimental | Therapeutic hypothermia using surface cooling device (Arctic Sun) Decompressive Hemicraniectomy care based on international guidelines except therapeutic hypothermia using surface cooling device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artic Sun | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rankin Scale | Functional outcome at 1 year modified Rankin Scale of 0 to 4 | 1 year after treatment |
| 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 |
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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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moon-ku Han | Contact | 82-31-787-7464 | mkhan@snu.ac.kr | |
| Han-gil Jeong | Contact | han.g.jeong@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moon-Ku Han | Seongnam-si | Bundang/kyeonggido | South Korea |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 6 month after treatment |