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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by University of Washington.
Recruitment status was:  Active, not recruiting
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Washington Identifier:
First received: February 11, 2010
Last updated: October 31, 2012
Last verified: October 2012

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traumatic Brain Injury in Latin America: Lifespan Analysis

Resource links provided by NLM:

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 ]

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


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01068522

Hospital Viedma
Cochabamba, Bolivia
Hospital Japones
Santa Cruz de la Sierra, Bolivia
Hospital San Juan de Dios
Santa Cruz de la Sierra, Bolivia
Hospital San Juan de Dios
Tarija, Bolivia
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)
Principal Investigator: Randall M Chesnut, MD University of Washington, Harborview Medical Center, Seattle, WA
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Washington Identifier: NCT01068522     History of Changes
Other Study ID Numbers: 33888-B
1R01NS058302 ( US NIH Grant/Contract Award Number )
Study First Received: February 11, 2010
Last Updated: October 31, 2012

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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System processed this record on May 25, 2017