Ischemic Stroke, Thrombolytic Therapy
Conditions
Keywords
Therapeutic hypothermia
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.
Interventions
DEVICEArctic 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)
OTHERStandard 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.
DRUGSaline
Sponsors
Bard Medical Division C.R. Bard Inc
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactMOON-KU HAN, professor
Outcome results
None listed