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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 successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic hypothermia group | Experimental | Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun) |
|
| Control group | Other | Stroke care based on international guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Sun | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MOON-KU HAN, professor | Contact | 82-31-787-7464 | mkhan@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| MOON-KU HAN, professor | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang | Recruiting | Seongnam | Gyeoinggido | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40791183 | Derived | Jeong JH, Hong JH, Sohn SI, Park H, Chang JY, Yum KS, Kang J, Han MK. Mild Hypothermia After Endovascular Treatment for Acute Ischemic Stroke: A Pilot Randomized Controlled Trial. Stroke. 2025 Nov;56(11):3100-3107. doi: 10.1161/STROKEAHA.124.049762. Epub 2025 Aug 12. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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|
|
| Standard treatment | Other |
|
|
| Saline | Drug |
|
| within 5~7 days of symptom onset |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |