Safety and Feasibility Study of Targeted Temperature Management After ICH
Safety and Feasibility Study of Targeted Temperature Management After ICH
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.
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  GCS <6

 -  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.