Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

NCT04825418 | Unknown

• 1 other identifier: BETHLeHAM
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothermia

Keywords

therapeutic hypothermia

Outcome Measures

Primary Outcomes (1)

• Rankin Scale

  Functional outcome at 1 year modified Rankin Scale of 0 to 4

  1 year after treatment

Secondary Outcomes (2)

• Mortality

  6 month, 1 year after treatment

• Functional outcome

  6 month after treatment

Study Arms (1)

Therapeutic Hypothermia Group

EXPERIMENTAL

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

Device: Artic Sun

Interventions

Artic Sun DEVICE

1. Induction phase A. Temperature using by esophageal or bladder thermometer. B. Application of a surface cooling device (Arctic Sun) C. Target temperature: 35 ± 0.5 °C D. Induction should be initiated as soon as possible after surgery (less than 6 hours) 2. Maintain phase A. Maintain duration : at least 72 hours and duration can be prolonged according to patient's clinical status B. Use the bedside shivering assessment scale (BSAS) and anti-shivering protocol C. Neuromuscular blocker can be used according to the discretion of the attending physician D. Lung-protective ventilation strategies including low-tidal volume are recommended E. Prophylactic antibiotics can be used to prevent pneumonia during hypothermia 3. Rewarming phase A. Rewarming rate: 0.05 - 0.1 ℃/hr (about 20 - 40 hours) to 37 ℃

Also known as: Therapeutic Hypothermia Group

Therapeutic Hypothermia Group

Eligibility Criteria

• Age: 19 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Bard Medical Division C.R. Bard Inc: collaborator

Study Sites (1)

Moon-Ku Han

Seongnam-si, Bundang/kyeonggido, South Korea

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Moon-ku Han

CONTACT

82-31-787-7464; mkhan@snu.ac.kr

Han-gil Jeong

CONTACT

han.g.jeong@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: April 1, 2021

Record last verified: 2021-01

Locations

KR (1)