Safety and Feasibility Study of Targeted Temperature Management After ICH
This trial is active, not recruiting.
|Phase||phase 1/phase 2|
|Sponsor||Thomas Jefferson University|
|Collaborator||American Heart Association|
|Start date||January 2013|
|End date||June 2015|
|Trial size||50 participants|
|Trial identifier||NCT01607151, 12CRP12050342|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Severe adverse events (SAEs)
time frame: 90 days
In-hospital neurological deterioration between day 0-7
time frame: 7 days
time frame: Discharge and 90 days
time frame: 24 hours
time frame: 24, 48,72, and 168-hours
Male or female participants at least 18 years old.
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.
|Official title||Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage|
|Principal investigator||Fred Rincon, MD, MSc|
|Description||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.|
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