Safety and Feasibility Study of Targeted Temperature Management After ICH

NCT ID: NCT01607151

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Normothermia

Core temperature 36-37 C

Group Type: ACTIVE_COMPARATOR

Normothermia

Intervention Type: OTHER

72 hours of targeted temperature management to achieve normothermia (36-37°C)

Hypothermia

Core temperature 32-34 C

Group Type: EXPERIMENTAL

Hypothermia

Intervention Type: OTHER

72 hours of targeted temperature management to achieve hypothermia (32-34°C)

Interventions

Normothermia

72 hours of targeted temperature management to achieve normothermia (36-37°C)

Intervention Type: OTHER

Hypothermia

72 hours of targeted temperature management to achieve hypothermia (32-34°C)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred Rincon, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

12CRP12050342

Identifier Type: -

Identifier Source: org_study_id