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Study to Improve Outcomes for Survivors of Traumatic Brain Injury in Latin America

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01068522
First received: February 11, 2010
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

People who survive severe traumatic brain injury (TBI) live with profound cognitive impairments that alter their developmental course and define their future possibilities. Worldwide, TBI is the leading cause of death and disability among children and adolescents (Murgio, 2000). In the United States, the annual incidence of TBI is six times greater than that of multiple sclerosis, HIV/AIDS, spinal cord injury, and breast cancer combined [Centers for Disease Control, American Cancer Society, National Multiple Sclerosis Society]. The burden of TBI may be even greater in developing countries, due to civil unrest and war, and to the absence of mandated prevention such as seat belt laws.

The long-term objective of the investigators' research group is to improve outcomes for survivors of TBI in Latin America. To that end, the investigators have created a structure for professionals and institutions involved in the treatment of TBI to generate research; to facilitate education, standardization, certification, the dissemination of information and resources; and to foster the development of evidence-based guidelines. The structure is the Latin American Brain Injury Consortium (LABIC).


Condition Intervention Phase
Traumatic Brain Injury
Brain Injuries
 Device: Parenchymal Intracranial pressure monitor
Other: Treatment based on clinical and imaging observations
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traumatic Brain Injury in Latin America: Lifespan Analysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • In a randomized controlled trial in 3 trauma centers in Bolivia, test the effect on outcomes of management of severe TBI guided by information from ICP monitors vs. a standard empiric protocol. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 324
Study Start Date: July 2007
Estimated Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICP monitoring
Care based upon intracranial pressure.
 Device: Parenchymal Intracranial pressure monitor
Treatment based on readings from Parenchymal intracranial pressure monitor.
Other Name: Integra Life Sciences Camino Intracranial Monitor
Active Comparator: Usual Care
Treatment based on clinical and imaging without intracranial pressure monitoring.
 Other: Treatment based on clinical and imaging observations
Treatment based on clinical and imaging observations.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • admission to study hospital within 24 hours of injury
  • closed head trauma
  • Glasgow Coma Scale (GCS) < 8 on admission or if intubated, GCS Motor < 5, within first 48 hours after injury
  • No foreign object in brain parenchyma

  • Randomized:

    • within 24 hours of injury [for patients with GCS < 8 on admission] or
    • within 24 hours of deterioration [patients deteriorating to GCS < 8 within 48 hours of injury]
  • Age > 12

Exclusion Criteria:

  • GCS of 3 with bilateral fixed and dilated pupils and/or decision to not actively treat prior to enrolment into study
  • No beds available in ICU
  • No ICP monitor available
  • Pregnancy
  • Prisoner
  • No consent
  • Non-survivable injury
  • Other (e.g., Pre-injury life expectancy under 1 year)
  • Pre-existing neurological disability that would not allow follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068522

Locations
Bolivia
Hospital Viedma
Cochabamba, Bolivia
Hospital San Juan de Dios
Santa Cruz de la Sierra, Bolivia
Hospital Japones
Santa Cruz de la Sierra, Bolivia
Hospital San Juan de Dios
Tarija, Bolivia
Ecuador
Hospital de Especialidades Eugenio Espejo
Espejo, Ecuador
Hospital Luis Vernaza
Guayaquil, Ecuador
Sponsors and Collaborators
University of Washington
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Randall M Chesnut, MD University of Washington, Harborview Medical Center, Seattle, WA
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01068522     History of Changes
Other Study ID Numbers: 33888-B, 1R01NS058302
Study First Received: February 11, 2010
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Intracranial pressure
Intracranial pressure monitoring
Head injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013