Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Severe adverse events (SAEs)
研究概览
简要总结
Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis for future larger clinical trials.
详细描述
Morbidity and mortality from intra-cerebral/intra-parenchymal hemorrhage (ICH/IPH) are important public health problems. As the most common etiology of ICH/IPH is hypertension, this places a large proportion of the population at risk. In 2011 The American Heart Association (AHA) estimated that in the US, there were 610,000 new stroke cases of which 10% were ICHs, and many required long-term health care. ICH/IPH is associated with the highest morbidity and mortality and only 20% of patients regain functional independence. Temperature modulation to hypothermia (T, 32-34°C) has been associated with modulation of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. Currently, there are no therapies to specifically target ICH/IPH. To this end, novel strategies that go beyond control of glucose, blood pressure, and intra-cranial pressure, aimed at reducing the enlargement of the hematoma and "swelling" surrounding it, could be "the new frontier in the management of ICH/IPH". Since the early resuscitation phase in the Neuro-ICU represents the greatest opportunity for impact on clinical outcome after ICH/IPH, it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating novel therapies.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous supratentorial ICH documented by CT scan within 18 hours after the onset of symptoms
- •Admission to the Neuro-ICU
- •Baseline hematoma >15cc with or without IVH
- •Need for mechanical ventilation.
排除标准
- •Age <18 years
- •Pregnancy
- •Pre-morbid modified Rankin Scale (mRS) >2
- •Do Not Resuscitate (DNR) order "prior" to enrollment
- •Uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding [UGIB/LGIB])
- •Planned surgical decompression within 24 hours
- •Secondary causes of ICH (ischemic stroke, coagulopathy [INR>1.4, aPTT> 1.5 times baseline, thrombocytopenia platelets <100,000/uL], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes)
- •Evidence of sepsis
- •Spontaneous hypothermia (core Temperature <36C)
- •Inability to obtain written informed consent
- •Participation in another trial.
结局指标
主要结局
Severe adverse events (SAEs)
时间窗: 90 days
The primary outcome measures will be: a) the frequency of adverse events (AEs) that will be possibly or probably related to treatment. AEs will be assessed up to 15-days after admission or discharge if earlier, and b) the frequency of severe adverse events (SAEs) that will be possibly and probably related to treatment.
次要结局
- In-hospital neurological deterioration between day 0-7(7 days)
- Functional outcome(Discharge and 90 days)
- Hematoma growth(24 hours)
- Cerebral edema(24, 48,72, and 168-hours)