Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Mar 30, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of using mild cooling (called hypothermia) combined with a surgical procedure known as decompressive hemicraniectomy in patients who have suffered a severe stroke caused by blocked blood flow to the brain. The goal is to see if this combination is safe and can help patients recover better than if they only had the surgery.

To be eligible for this trial, participants must be adults between the ages of 19 and 82 who have experienced a specific type of stroke and have significant symptoms, including a loss of consciousness. They should also be able to give consent or have a representative who can do so. The trial is not yet recruiting participants, but if you or someone you know might fit these criteria, it could be an important opportunity to explore a new treatment approach. Participants will receive close medical care and monitoring throughout the trial to ensure their safety.

Gender

ALL

Eligibility criteria

• 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