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

This study is currently recruiting participants.
Verified March 2014 by Thomas Jefferson University
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01607151
First received: May 24, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Intracerebral Hemorrhage
Other: Normothermia
Other: Hypothermia
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607151

Contacts
Contact: Fred Rincon, MD, MSc 215-503-9905 fred.rincon@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: John Furlong, RN    215-955-7301    John.furlong@jefferson.edu   
Principal Investigator: Fred Rincon, MD, MSc         
Sponsors and Collaborators
Thomas Jefferson University
American Heart Association
Investigators
Principal Investigator: Fred Rincon, MD, MSc Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01607151     History of Changes
Other Study ID Numbers: 12CRP12050342
Study First Received: May 24, 2012
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
hypothermia
normothermia
hyperthermia

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014