Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

NCT00178711 | Terminated Phase 3 Results DMC

• 2 other identifiers: 5U01NS043353-06FDA-2014-109
• Study Type: interventional
• Target: 232
• Locations: 2 countries
• Sites: 5

Brief Summary

Induction of hypothermia to \< 35˚C by \< 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Hypothermia

Outcome Measures

Primary Outcomes (1)

• The Dichotomized Glasgow Outcome Scale

  The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.

  6 months with a window of plus or minus one month

Other Outcomes (9)

• Glasgow Outcome Scale - Extended

  0-12 months

• Disability Rating Scale

  assessed 0-12 months

• Neurobehavioral Rating Scale - Revised

  0-12 months

Study Arms (2)

hypothermia

ACTIVE COMPARATOR

Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours.

Device: Hypothermia

control

NO INTERVENTION

treated at normothermia

Interventions

Hypothermia DEVICE

Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours

Also known as: moderate hypothermia

hypothermia

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) \< 8 (motor 1-5)
• Estimated or known age \> 16 and \< 45 years old
• Time of Injury within 2.5hrs of arrival at hospital

You may not qualify if:

• GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS \> 9 post- randomization
• GCS = 3 AND bilaterally non-reactive pupils
• Abbreviated Injury Score (AIS) \> 4 for any body area except head
• Positive abdominal ultrasound or CT scan
• Persistent hypotension (systolic blood pressure \< 110mmHGg)
• Persistent hypoxia (O2 Saturation \< 94%)
• Positive pregnancy test
• Injured greater than 2.5 hours from hospital arrival
• Pre-existing medical conditions, if known

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (5)

University of St Louis : St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

University of Pittsburgh : University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Health Science Center, Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

University of Calgary Health Science Center : Foothills Medical Center

Calgary, Alberta, T2N4N1, Canada

Location

Related Publications (2)

• Clifton GL, Coffey CS, Fourwinds S, Zygun D, Valadka A, Smith KR Jr, Frisby ML, Bucholz RD, Wilde EA, Levin HS, Okonkwo DO. Early induction of hypothermia for evacuated intracranial hematomas: a post hoc analysis of two clinical trials. J Neurosurg. 2012 Oct;117(4):714-20. doi: 10.3171/2012.6.JNS111690. Epub 2012 Jul 27.

  PMID: 22839656 RESULT

• Clifton GL, Valadka A, Zygun D, Coffey CS, Drever P, Fourwinds S, Janis LS, Wilde E, Taylor P, Harshman K, Conley A, Puccio A, Levin HS, McCauley SR, Bucholz RD, Smith KR, Schmidt JH, Scott JN, Yonas H, Okonkwo DO. Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet Neurol. 2011 Feb;10(2):131-9. doi: 10.1016/S1474-4422(10)70300-8. Epub 2010 Dec 17.

  PMID: 21169065 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Limitations and Caveats

Early termination for futility.

Results Point of Contact

• Title: Guy L Clifton
• Organization: University of Texas Health Science Center

guy@guyclifton.com

2024224824

Study Officials

• Guy L Clifton, MD

  UTHSC-H

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Neurosurgery

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 17, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-09

Locations

US (4); CA (1)