Overview

This trial is active, not recruiting.

Condition intracerebral hemorrhage
Treatments normothermia, hypothermia
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Core temperature 36-37 C
normothermia
72 hours of targeted temperature management to achieve normothermia (36-37°C)
(Experimental)
Core temperature 32-34 C
hypothermia
72 hours of targeted temperature management to achieve hypothermia (32-34°C)

Primary Outcomes

Measure
Severe adverse events (SAEs)
time frame: 90 days

Secondary Outcomes

Measure
In-hospital neurological deterioration between day 0-7
time frame: 7 days
Functional outcome
time frame: Discharge and 90 days
Hematoma growth
time frame: 24 hours
Cerebral edema
time frame: 24, 48,72, and 168-hours

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Thomas Jefferson University.