Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Seoul National University

Status: Not yet enrolling

Conditions: Hypothermia

Treatments: Device: Artic Sun

Study type: Interventional

Funder types: Other

Identifiers

NCT04825418

BETHLeHAM

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 19 to 82 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Therapeutic Hypothermia Group

Experimental group

Description:

Therapeutic hypothermia using surface cooling device (Arctic Sun) Decompressive Hemicraniectomy care based on international guidelines except therapeutic hypothermia using surface cooling device.

Treatment:

Device: Artic Sun