Safety and Feasibility Study of Targeted Temperature Management After ICH
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | June 2016 |
Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage
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.
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.
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.
We found this trial at
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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