Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— HELMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02985060
• Other study ID #: HELMET ver1.1
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2016
• Last updated: December 12, 2016
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: Seoul National University Hospital
• Contact: MOON-KU HAN, professor
• Phone: 82-31-787-7464
• Email: mkhan[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Hypothermia
• Ischemia
• Ischemic Stroke
• Stroke
• Thrombolytic Therapy

Intervention

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:
• 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.

Drug:
• Saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang	Seongnam	Gyeoinggido

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bard Medical Division C.R. Bard Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable outcome	modified Rankin Scale of 0-2 points at 3 months	3 months after symptom onset	No
Primary	mortality at 3 months	mortality at 3 months	3 months after symptom onset	Yes
Secondary	Improvements in neurological functions	Changes in the cerebral infarction lesions at 5~7 days	Volume change on diffusion lesion at 5~7 days	No
Secondary	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	within 5~7 days of symptom onset	Yes