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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

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Therapeutic hypothermia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

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

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

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

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

mkhan@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

JEONG-HO HONG, professor

Phone

82-53-250-7317

neurohong79@mail.com

12. IPD Sharing Statement

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Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

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