HELMET: Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02985060

Collaborator

Bard Medical Division C.R. Bard Inc (Other)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Thrombolytic Therapy	Device: Arctic Sun Other: Standard treatment Drug: Saline	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapeutic hypothermia group Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)	Device: Arctic Sun 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) Other Names: Therapeutic hypothermia Drug: Saline
Other: Control group Stroke care based on international guidelines	Other: Standard treatment 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.

Arm

Intervention/Treatment

Experimental: Therapeutic hypothermia group

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

Device: Arctic Sun

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)

Other Names:

Therapeutic hypothermia

Drug: Saline

Other: Control group

Stroke care based on international guidelines

Other: Standard treatment

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.

Outcome Measures

Primary Outcome Measures

Favorable outcome [3 months after symptom onset]
modified Rankin Scale of 0-2 points at 3 months
mortality at 3 months [3 months after symptom onset]
mortality at 3 months

Secondary Outcome Measures

Improvements in neurological functions [Volume change on diffusion lesion at 5~7 days]
Changes in the cerebral infarction lesions at 5~7 days
Symptomatic cerebral hemorrhage [within 5~7 days of symptom onset]
deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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