Mild Hypothermia in Acute Ischemic Stroke After Thrombolytic Therapy: a Prospective,Open,Randomized,Single-center,Safety and Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period.
研究概览
简要总结
Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with acute ischemic stroke.
详细描述
Fever is associated with higher stroke mortality and poor outcome, but it is yet unknown whether this association is causative or epiphenomenal.
In temporary brain ischemia rodent models hypothermia results in a significant increase in the number of surviving neurons and smaller infarction size as measured with histological examination after death.
Therapeutic effect has been shown in clinical trials in comatose cardiac arrest patients and newborn infants with perinatal hypoxic-ischemic brain injury.
Design: A prospective, open, randomized single-center study.
Study population: 36 patients, 18-85 years of age presenting with symptoms of acute ischemic hemispheric stroke with persisting significant neurological deficit (NIHSS 7-20 or NIHSS 2 for dysphasia or NIHSS 3 for paralysis of upper or lower limb) at 2 hours after thrombolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to Meilahti protocol
- •NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total NIHSS score
- •Symptom onset within 6 hour
排除标准
- •Platelet count < 75,000/mm3
- •Known coagulopathy (INR spontaneously >1.5)
- •Hemodynamical unstability
- •Recent history of angina pectoris or acute myocardial infarction
- •Sepsis within 72 hours
- •Pregnancy
- •Pre-existing neurological disability with modified Rankin Scale Score>2
- •Known allergy or intolerance to buspirone, dexmedetomidine, meperidine
- •Intracranial hemorrhage in brain CT scan
- •Intracranial mass lesion (i.e., abscess, tumor, or infection)
- •Participation in an other therapy trial within last 3 months
- •Hypothermia- treatment cannot be initiated within 6 hours of symptom onset
- •Protocol violation in thrombolytic therapy
- •Any condition where researchers assume that the patient is not suitable (must be reasoned)
结局指标
主要结局
The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period.
时间窗: 12 hours
次要结局
- The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events(14 days)
- All-cause mortality during acute phase (7 days), 1 month, and 3 month follow-up; and readmission to hospital for any reason within 3-months.(3 months)
- The proportion of modified Rankin Scale-responders (mRS 0-2), Barthel Index, NIHSS, Glasgow Outcome Scale(3 months)
- Neuropsychological tests(3 months)
- Size of infarction in MRI, and grading of the possible hemorrhagic transformation according to SITS scale (MRI includes scout images, DWI, T1, T2, FLAIR, T2*, and MR angiography)(3-7 days)
研究者
Katja Piironen
MD
University of Helsinki