Intracerebral Hemorrhage
Conditions
Keywords
hypothermia, normothermia, hyperthermia
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.
Interventions
OTHERNormothermia
72 hours of targeted temperature management to achieve normothermia (36-37°C)
OTHERHypothermia
72 hours of targeted temperature management to achieve hypothermia (32-34°C)
Sponsors
American Heart Association
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe adverse events (SAEs) | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital neurological deterioration between day 0-7 | 7 days | Decrease in GCS in ≥2 points or increase in the NIHSS ≥4 points |
| Functional outcome | Discharge and 90 days | Modified Rankin Scale at discharge and 90-days. |
| Hematoma growth | 24 hours | 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 | 24, 48,72, and 168-hours | The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio) |
Countries
United States
Outcome results
None listed