Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke (HELMET)

December 12, 2016 updated by: Moon Ku Han, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MOON-KU HAN, professor
  • Phone Number: 82-31-787-7464
  • Email: mkhan@snu.ac.kr

Study Locations

  • Korea, Republic of
    • Gyeoinggido
      • Seongnam, Gyeoinggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang
        • Contact:
          • MOON-KU HAN, professor
          • Phone Number: 82-31-787-7464
          • Email: mkhan@snu.ac.kr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.)
  2. 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.
  3. Patients of both sexes aged between 18 and 80 years old
  4. NIHSS scores of 6-25 points at screening
  5. 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:

  1. No evaluation for cranial artery before endovascular treatment
  2. Patient with emergent stenting insertion in intracranial or extracranial artery
  3. Transient ischemic attack or lacunar infarction
  4. Platelet counts < 75,000/mm3
  5. coagulopathy (INR spontaneously >1.5)
  6. Hemodynamic instability
  7. acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III)
  8. Sepsis
  9. Pregnant or breastfeeding women
  10. Premorbid modified Rankin Scale Scores of > 2 points
  11. Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine
  12. Intracranial hemorrhage or hemorrhagic transformation in initial CT scan
  13. Brain tumor or CNS infection
  14. Patients who participated in other clinical trials within 3 months
  15. Life expectancy within 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)
Drug: Saline
Device: Arctic Sun

  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)
Other Names:
  • Therapeutic hypothermia
Other: Control group
Stroke care based on international guidelines
Other: Standard treatment
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favorable outcome
Time Frame: 3 months after symptom onset
modified Rankin Scale of 0-2 points at 3 months
3 months after symptom onset
mortality at 3 months
Time Frame: 3 months after symptom onset
mortality at 3 months
3 months after symptom onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in neurological functions
Time Frame: Volume change on diffusion lesion at 5~7 days
Changes in the cerebral infarction lesions at 5~7 days
Volume change on diffusion lesion at 5~7 days
Symptomatic cerebral hemorrhage
Time Frame: 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
within 5~7 days of symptom onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Bard Medical Division C.R. Bard Inc

Investigators

  • Principal Investigator: MOON-KU HAN, professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELMET ver1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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