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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01607151
Recruitment Status : Unknown
Verified August 2015 by Thomas Jefferson University.
Recruitment status was:  Active, not recruiting
First Posted : May 28, 2012
Last Update Posted : August 5, 2015
American Heart Association
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Other: Normothermia Other: Hypothermia Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hypothermia

Arm Intervention/treatment
Active Comparator: Normothermia
Core temperature 36-37 C
Other: Normothermia
72 hours of targeted temperature management to achieve normothermia (36-37°C)

Experimental: Hypothermia
Core temperature 32-34 C
Other: Hypothermia
72 hours of targeted temperature management to achieve hypothermia (32-34°C)

Primary Outcome Measures :
  1. Severe adverse events (SAEs) [ Time Frame: 90 days ]
    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.

Secondary Outcome Measures :
  1. In-hospital neurological deterioration between day 0-7 [ Time Frame: 7 days ]
    Decrease in GCS in ≥2 points or increase in the NIHSS ≥4 points

  2. Functional outcome [ Time Frame: Discharge and 90 days ]
    Modified Rankin Scale at discharge and 90-days.

  3. Hematoma growth [ Time Frame: 24 hours ]
    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

  4. Cerebral edema [ Time Frame: 24, 48,72, and 168-hours ]
    The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01607151

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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
American Heart Association
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Principal Investigator: Fred Rincon, MD, MSc Thomas Jefferson University
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Responsible Party: Thomas Jefferson University Identifier: NCT01607151    
Other Study ID Numbers: 12CRP12050342
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by Thomas Jefferson University:
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases