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Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04825418
Collaborator
Bard Medical Division C.R. Bard Inc (Other)
35
Enrollment
1
Location
1
Arm
55
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Artic Sun
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Beneficial Effect of Therapeutic Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy Alone in Patients With Malignant Cerebral Infarction (BETHLeHAM Study) - Prospective, Open, Single-arm, Multicenter Phase II Study
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapeutic Hypothermia Group

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
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) 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 Rewarming phase A. Rewarming rate: 0.05 - 0.1 ℃/hr (about 20 - 40 hours) to 37 ℃
Other Names:
  • Therapeutic Hypothermia Group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rankin Scale [1 year after treatment]

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

    Secondary Outcome Measures

    1. Mortality [6 month, 1 year after treatment]

      Mortality at 6 month, 1 year

    2. Functional outcome [6 month after treatment]

      6 month modified Rankin Scale of 0 to 4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 82 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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:

    1. Premorbid modified Rankin Scale (mRS) score ≥ 2 B. Presence of other type of brain lesions including traumatic brain injury, contralateral or infratentorial infarct.

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moon-Ku Han Seongnam-si Bundang/kyeonggido Korea, Republic of

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT04825418
    Other Study ID Numbers:
    • BETHLeHAM
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seoul National University Hospital
    therapeutic hypothermia
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Apr 1, 2021