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Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Primary Purpose

Hypothermia

Status

Not yet recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Artic Sun

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring therapeutic hypothermia

Eligibility Criteria

19 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Moon-Ku Han

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Hypothermia Group

Arm Description

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

Outcomes

Primary Outcome Measures

Rankin Scale

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

Secondary Outcome Measures

Mortality

Mortality at 6 month, 1 year

Functional outcome

6 month modified Rankin Scale of 0 to 4

Full Information

NCT ID

NCT04825418

First Posted

March 28, 2021

Last Updated

March 30, 2021

Sponsor

Seoul National University Hospital

Collaborators

Bard Medical Division C.R. Bard Inc

1. Study Identification

Unique Protocol Identification Number

NCT04825418

Brief Title

Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Bard Medical Division C.R. Bard Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothermia

Keywords

therapeutic hypothermia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapeutic Hypothermia Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Artic Sun

Other Intervention Name(s)

Therapeutic Hypothermia Group

Intervention Description

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 ℃

Primary Outcome Measure Information:

Title

Rankin Scale

Description

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

Time Frame

1 year after treatment

Secondary Outcome Measure Information:

Title

Mortality

Description

Mortality at 6 month, 1 year

Time Frame

6 month, 1 year after treatment

Title

Functional outcome

Description

6 month modified Rankin Scale of 0 to 4

Time Frame

6 month after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

82 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moon-ku Han

Phone

82-31-787-7464

mkhan@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Han-gil Jeong

han.g.jeong@gmail.com

Facility Information:

Facility Name

Moon-Ku Han

City

Seongnam-si

State/Province

Bundang/kyeonggido

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moon-ku Han

Phone

82-31-787-7464

mkhan@snu.ac.kr

12. IPD Sharing Statement

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Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

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