Status:
UNKNOWN
Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Bard Medical Division C.R. Bard Inc
Conditions:
Hypothermia
Eligibility:
All Genders
19-82 years
Phase:
NA
Brief Summary
To study safety and feasibility of mild therapeutic hypothermia after decompressive hemicraniectomy compared with hemicraniectomy alone in patients with malignant cerebral infarction
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04825418
Start Date
May 1 2021
End Date
December 1 2025
Last Update
April 1 2021
Active Locations (1)
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1
Moon-Ku Han
Seongnam-si, Bundang/kyeonggido, South Korea