Safety and Feasibility Study of Targeted Temperature Management After ICH (TTM-ICH)

• Severe adverse events (SAEs) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  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.
  
  

• In-hospital neurological deterioration between day 0-7 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  Decrease in GCS in ≥2 points or increase in the NIHSS ≥4 points
  
  
• Functional outcome [ Time Frame: Discharge and 90 days ] [ Designated as safety issue: Yes ]
  Modified Rankin Scale at discharge and 90-days.
  
  
• Hematoma growth [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  Absolute change in hematoma between baseline and 24 hours CT-scan and new or absolute change in IVH between baseline and 24 hours CT-scan
  
  
• Cerebral edema [ Time Frame: 24, 48,72, and 168-hours ] [ Designated as safety issue: Yes ]
  The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio)
  
  

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.