Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

Hypothermia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04825418
• Other study ID #: BETHLeHAM
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2021
• Source: Seoul National University Hospital
• Contact: Moon-ku Han
• Phone: 82-31-787-7464
• Email: mkhan[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

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 ?

Locations

Country	Name	City	State
Korea, Republic of	Moon-Ku Han	Seongnam-si	Bundang/kyeonggido

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bard Medical Division C.R. Bard Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rankin Scale	Functional outcome at 1 year modified Rankin Scale of 0 to 4	1 year after treatment
Secondary	Mortality	Mortality at 6 month, 1 year	6 month, 1 year after treatment
Secondary	Functional outcome	6 month modified Rankin Scale of 0 to 4	6 month after treatment