Clinical trial NCT01607151: Safety and Feasibility Study of Targeted Temperature Management After ICH
Official title: Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: hypothermia
normothermia
hyperthermia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2012-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severe adverse events (SAEs)
timeFrame: 90 days
Secondary outcomes:
measure: In-hospital neurological deterioration between day 0-7
timeFrame: 7 days
measure: Functional outcome
timeFrame: Discharge and 90 days
measure: Hematoma growth
timeFrame: 24 hours
measure: Cerebral edema
timeFrame: 24, 48,72, and 168-hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Fred Rincon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: