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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 30, 2014