Phase III Hypothermia Clinical Trial - Full Text View

Purpose

The Primary Hypothesis for this application for a multicenter Phase III Randomized Clinical Trial (RCT) is that induced moderate hypothermia (HYPO) (32-33°C) after severe TBI in children and maintained for 48 h will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).

Condition	Intervention	Phase
Traumatic Brain Injury	Procedure: induced moderate hypothermia	Phase III

MedlinePlus related topics:

Head and Brain Injuries Hypothermia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study

Official Title:	Pediatric Traumatic Brain Injury Consortium: Hypothermia

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

The Primary Specific Aim of this RCT is to determine the effect of induced moderate HYPO (32-33°C) after severe TBI in children on mortality. [ Time Frame: 3 month post injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the effect of HYPO after severe TBI in children on global function and neurocognitive outcomes in the areas of intellectual ability/ development, memory and learning, and behavior. [ Time Frame: at 6 and 12 months post injury ] [ Designated as safety issue: No ]
To determine the effect of HYPO after severe TBI in children of different age ranges (< 6 y and 6- < 16 y) on mortality and 6 and 12 months functional and neurocognitive outcomes. [ Time Frame: 3, 6 and 12 months post injury ] [ Designated as safety issue: No ]
To determine the effect of HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure (CPP). [ Time Frame: 7 days post injury ] [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Induced hypothermia	Procedure: induced moderate hypothermia Subjects assigned to the treatment arm will be cooled to 32-33C for 48 hours and then slowly rewarmed.

Detailed Description:

The Primary Specific Aim of this RCT is to determine the effect of induced moderate HYPO (32-33°C) after severe TBI in children on mortality at 3 months post injury. The primary outcome measure will be the GOS; the primary time point for evaluation is 3 months. Further secondary functional outcome measures will include the GOS- Extended Pediatrics (GOS- E Peds), and Vineland Adaptive Behavior Scale (VABS) and will be assessed in conjunction with the GOS at 6 and 12 months post injury.

The Secondary Hypotheses are based on the results and analysis of the Pilot Clinical Trial (completed and recently published [Adelson et al. NEUROSURGERY. 56 (4): 740-754, 2005]). These secondary hypotheses include that induced moderate hypothermia (HYPO) (32-33°C) after severe TBI in children and maintained for 48 h: 1) will improve other outcome assessments including neurocognitive status on performance-based neuropsychological testing across the domains of intellectual development, learning and memory, language, motor and psychomotor skills, visuo-spatial abilities, attention and executive function, and behavior at only 6 and 12 months after injury; 2) HYPO will improve long term outcome of all age ranges and across genders in infants, young, preadolescent, and adolescent children; and 3) HYPO will lessen intracranial hypertension and lessen the intensity of therapy necessary for control of ICP. Based on these hypotheses, further secondary specific aims are proposed:

Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a GCS </= 8,
Glasgow Motor Score < 6
Close head injury
Age 0 - < 16 y

Exclusion Criteria

Normal CT scan
Penetrating Brain Injury
Post resuscitation GCS 3
> 6 hours from injury
Brain Dead on Admission to ED
Unavailable to initiate cooling within 6 h of injury
Uncorrectable coagulopathy (PT/PTT >16/40 sec, INR >1.7)
Hypotensive episode defined as Systolic Blood Pressure < 5th percentile for age > 10 min
Hypoxia episode defined as O2 saturation < 94% for > 30 min. post resuscitation
Follow up unlikely (e.g., distance from treating center, illegal alien, etc.)
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222742

Contacts


Contact: P. David Adelson, MD	412-692-6347	david.adelson@chp.edu

Contact: S. Danielle Brown, RN, MS	412-692-8794	brownds2@upmc.edu

Locations


United States, California
	University of California, Davis Medical Center	Not yet recruiting
	Sacramento, California, United States, 95817
	Principal Investigator: Kiarash Shahlaie, MD, PhD

United States, Florida
	University of Miami	Recruiting
	Miami, Florida, United States, 33136
	Principal Investigator: John Ragheb, MD

United States, Maryland
	Johns Hopkins University	Not yet recruiting
	Baltimore, Maryland, United States, 21287
	Principal Investigator: George Jallo, MD

United States, New York
	Schneider Children's Hospital	Recruiting
	New Hyde Park, New York, United States, 11040
	Principal Investigator: Stephen Schneider, MD

United States, North Carolina
	University of North Carolina	Not yet recruiting
	Chapel Hill, North Carolina, United States, 25799
	Principal Investigator: Stephen Leinenweber, MD
	Duke University	Recruiting
	Durham, North Carolina, United States, 27710
	Contact: Gerald Grant, MD 919-684-5013 gerald.grant@duke.edu
	Principal Investigator: Gerald Grant, MD
	Sub-Investigator: Mary Hartman, MD

United States, Ohio
	Cincinnati Children's Hospital Medical Center	Recruiting
	Cincinnati, Ohio, United States, 47229-3039
	Contact: Karin Bierbrauer, MD 513-636-4726 karin.bierbrauer@cchmc.org
	Principal Investigator: Karin Bierbrauer, MD

United States, Pennsylvania
	University of Pittsburgh/Children's Hospital of Pittsburgh	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Michael J Bell, MD 412-692-5164 bellmj4@upmc.edu
	Principal Investigator: Michael Bell, MD
	Penn State Hershey Medical Center	Recruiting
	Hershey, Pennsylvania, United States, 17033
	Contact: Neal J Thomas, MD, M.Sc. 717-531-5337 nthomas@psu.edu
	Principal Investigator: Neal Thomas, MD

United States, Tennessee
	University of Tennessee	Not yet recruiting
	Memphis, Tennessee, United States, 38163
	Contact: Shelley D Timmons, MD, PhD 901-448-6375 stimmons@utmem.edu
	Principal Investigator: Shelley D Timmons, MD, PhD

United States, Texas
	University of Texas, Southwestern	Recruiting
	Dallas, Texas, United States, 75235
	Principal Investigator: Pam Okada, MD
	Sub-Investigator: Marita Thompson, MD
	Sub-Investigator: Steven Kernie, MD

United States, Washington
	University of Washington	Not yet recruiting
	Seattle, Washington, United States, 98104
	Principal Investigator: Randall Chesnut, MD
	Sub-Investigator: Monica Vavilala, MD

Sponsors and Collaborators

University of Pittsburgh

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators


Principal Investigator:	P. David Adelson, MD	University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh ( P. David Adelson, MD )
Study ID Numbers:	1R01-NS052478-01, 1R01NS052478-01
First Received:	September 16, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00222742
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

hypothermia; pediatric TBI

Study placed in the following topic categories:

Craniocerebral Trauma

Signs and Symptoms

Hypothermia

Wounds and Injuries

Disorders of Environmental Origin

Central Nervous System Diseases

Trauma, Nervous System

Brain Diseases

Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

Body Temperature Changes

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	University of Pittsburgh National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00222742