Safety and Feasibility Study of Targeted Temperature Management After ICH (TTM-ICH)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage|
- Severe adverse events (SAEs) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]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.
- In-hospital neurological deterioration between day 0-7 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Decrease in GCS in ≥2 points or increase in the NIHSS ≥4 points
- Functional outcome [ Time Frame: Discharge and 90 days ] [ Designated as safety issue: Yes ]Modified Rankin Scale at discharge and 90-days.
- Hematoma growth [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]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 [ Time Frame: 24, 48,72, and 168-hours ] [ Designated as safety issue: Yes ]The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio)
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Normothermia
Core temperature 36-37 C
72 hours of targeted temperature management to achieve normothermia (36-37°C)
Core temperature 32-34 C
72 hours of targeted temperature management to achieve hypothermia (32-34°C)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607151
|Contact: Fred Rincon, MD, MScemail@example.com|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: John Furlong, RN 215-955-7301 John.firstname.lastname@example.org|
|Principal Investigator: Fred Rincon, MD, MSc|
|Principal Investigator:||Fred Rincon, MD, MSc||Thomas Jefferson University|