Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

NCT ID: NCT02985060

Last Updated: 2016-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Ischemic Stroke; Thrombolytic Therapy

Keywords

Therapeutic hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Arctic Sun

Intervention Type: DEVICE

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)

Saline

Intervention Type: DRUG

Control group

Stroke care based on international guidelines

Group Type: OTHER

Standard treatment

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Saline

Intervention Type: DRUG

Other Intervention Names

Therapeutic hypothermia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bard Medical Division C.R. Bard Inc

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Moon Ku Han

proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MOON-KU HAN, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang

Seongnam, Gyeoinggido, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

MOON-KU HAN, professor

Role: CONTACT

Phone: 82-31-787-7464

Email: mkhan@snu.ac.kr

Facility Contacts

MOON-KU HAN, professor

Role: primary

JEONG-HO HONG, professor

Role: backup

References

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 Aug 12. doi: 10.1161/STROKEAHA.124.049762. Online ahead of print.

Reference Type: DERIVED

PMID: 40791183 (View on PubMed)

Other Identifiers

HELMET ver1.1

Identifier Type: -

Identifier Source: org_study_id