Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke (HELMET)
Primary Purpose
Ischemic Stroke, Thrombolytic Therapy
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arctic Sun
Standard treatment
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Therapeutic hypothermia
Eligibility Criteria
Inclusion Criteria:
- Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.)
- Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal.
- Patients of both sexes aged between 18 and 80 years old
- NIHSS scores of 6-25 points at screening
- mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery)
Exclusion Criteria:
- No evaluation for cranial artery before endovascular treatment
- Patient with emergent stenting insertion in intracranial or extracranial artery
- Transient ischemic attack or lacunar infarction
- Platelet counts < 75,000/mm3
- coagulopathy (INR spontaneously >1.5)
- Hemodynamic instability
- acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III)
- Sepsis
- Pregnant or breastfeeding women
- Premorbid modified Rankin Scale Scores of > 2 points
- Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine
- Intracranial hemorrhage or hemorrhagic transformation in initial CT scan
- Brain tumor or CNS infection
- Patients who participated in other clinical trials within 3 months
- Life expectancy within 1 year
Sites / Locations
- Seoul National University BundangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Therapeutic hypothermia group
Control group
Arm Description
Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
Stroke care based on international guidelines
Outcomes
Primary Outcome Measures
Favorable outcome
modified Rankin Scale of 0-2 points at 3 months
mortality at 3 months
mortality at 3 months
Secondary Outcome Measures
Improvements in neurological functions
Changes in the cerebral infarction lesions at 5~7 days
Symptomatic cerebral hemorrhage
deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image
Full Information
NCT ID
NCT02985060
First Posted
December 5, 2016
Last Updated
December 12, 2016
Sponsor
Seoul National University Hospital
Collaborators
Bard Medical Division C.R. Bard Inc
1. Study Identification
Unique Protocol Identification Number
NCT02985060
Brief Title
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke
Acronym
HELMET
Official Title
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Bard Medical Division C.R. Bard Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.
Detailed Description
The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Thrombolytic Therapy
Keywords
Therapeutic hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic hypothermia group
Arm Type
Experimental
Arm Description
Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
Arm Title
Control group
Arm Type
Other
Arm Description
Stroke care based on international guidelines
Intervention Type
Device
Intervention Name(s)
Arctic Sun
Other Intervention Name(s)
Therapeutic hypothermia
Intervention Description
Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered.
Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed
Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours
Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours)
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines.
In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke.
Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days.
Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Favorable outcome
Description
modified Rankin Scale of 0-2 points at 3 months
Time Frame
3 months after symptom onset
Title
mortality at 3 months
Description
mortality at 3 months
Time Frame
3 months after symptom onset
Secondary Outcome Measure Information:
Title
Improvements in neurological functions
Description
Changes in the cerebral infarction lesions at 5~7 days
Time Frame
Volume change on diffusion lesion at 5~7 days
Title
Symptomatic cerebral hemorrhage
Description
deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image
Time Frame
within 5~7 days of symptom onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.)
Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal.
Patients of both sexes aged between 18 and 80 years old
NIHSS scores of 6-25 points at screening
mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery)
Exclusion Criteria:
No evaluation for cranial artery before endovascular treatment
Patient with emergent stenting insertion in intracranial or extracranial artery
Transient ischemic attack or lacunar infarction
Platelet counts < 75,000/mm3
coagulopathy (INR spontaneously >1.5)
Hemodynamic instability
acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III)
Sepsis
Pregnant or breastfeeding women
Premorbid modified Rankin Scale Scores of > 2 points
Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine
Intracranial hemorrhage or hemorrhagic transformation in initial CT scan
Brain tumor or CNS infection
Patients who participated in other clinical trials within 3 months
Life expectancy within 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOON-KU HAN, professor
Phone
82-31-787-7464
Email
mkhan@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOON-KU HAN, professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang
City
Seongnam
State/Province
Gyeoinggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOON-KU HAN, professor
Phone
82-31-787-7464
Email
mkhan@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
JEONG-HO HONG, professor
Phone
82-53-250-7317
Email
neurohong79@mail.com
12. IPD Sharing Statement
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Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke
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