Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Not Applicable

Not yet recruiting

• Conditions: Hypothermia
• Interventions: Device: Artic Sun

• Registration Number: NCT04825418
• Lead Sponsor: Seoul National University Hospital

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 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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Study Start: 2021-05
• Primary Completion: 2022-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rankin Scale	1 year after treatment	Functional outcome at 1 year modified Rankin Scale of 0 to 4

Secondary Outcome Measures

Name	Time	Method
Functional outcome	6 month after treatment	6 month modified Rankin Scale of 0 to 4
Mortality	6 month, 1 year after treatment	Mortality at 6 month, 1 year

Trial Locations

Locations (1)

Moon-Ku Han; 🇰🇷 Seongnam-si, Bundang/kyeonggido, Korea, Republic of