Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke
HELMET
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedDecember 13, 2016
December 1, 2016
1 year
December 5, 2016
December 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Favorable outcome
modified Rankin Scale of 0-2 points at 3 months
3 months after symptom onset
mortality at 3 months
mortality at 3 months
3 months after symptom onset
Secondary Outcomes (2)
Improvements in neurological functions
Volume change on diffusion lesion at 5~7 days
Symptomatic cerebral hemorrhage
within 5~7 days of symptom onset
Study Arms (2)
Therapeutic hypothermia group
EXPERIMENTALTherapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
Control group
OTHERStroke care based on international guidelines
Interventions
1. 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 2. Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours 3. Recovery phase:Rewarming velocity: 0.05\~0.1℃ (within 30 hours)
1. All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines. 2. 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. 3. Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days. 4. Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang
Seongnam, Gyeoinggido, 13620, South Korea
Related Publications (1)
Jeong JH, Hong JH, Sohn SI, Park H, Chang JY, Yum KS, Kang J, Han MK. Mild Hypothermia After Endovascular Treatment for Acute Ischemic Stroke: A Pilot Randomized Controlled Trial. Stroke. 2025 Nov;56(11):3100-3107. doi: 10.1161/STROKEAHA.124.049762. Epub 2025 Aug 12.
PMID: 40791183DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MOON-KU HAN, professor
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- proffessor
Study Record Dates
First Submitted
December 5, 2016
First Posted
December 7, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
December 13, 2016
Record last verified: 2016-12