Safety and Feasibility Study of Targeted Temperature Management After ICH (TTM-ICH)

Thomas Jefferson University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Intracerebral Hemorrhage

Treatments

Other: Hypothermia

Other: Normothermia

Study type

Interventional

Funder types

Other

Identifiers

NCT01607151

12CRP12050342

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.