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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermia | Active Comparator | Core temperature 36-37 C |
|
| Hypothermia | Experimental | Core temperature 32-34 C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normothermia | Other | 72 hours of targeted temperature management to achieve normothermia (36-37°C) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe adverse events (SAEs) | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital neurological deterioration between day 0-7 | Decrease in GCS in ≥2 points or increase in the NIHSS ≥4 points | 7 days |
| Functional outcome | Modified Rankin Scale at discharge and 90-days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Rincon, MD, MSc | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D007035 | Hypothermia |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Hypothermia | Other | 72 hours of targeted temperature management to achieve hypothermia (32-34°C) |
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| Discharge and 90 days |
| Hematoma growth | 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 | 24 hours |
| Cerebral edema | The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio) | 24, 48,72, and 168-hours |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |