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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01068522
Recruitment Status : Unknown
Verified October 2012 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : February 15, 2010
Last Update Posted : November 1, 2012
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Washington

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traumatic Brain Injury in Latin America: Lifespan Analysis
Study Start Date : July 2007
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068522

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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)
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Principal Investigator: Randall M Chesnut, MD University of Washington, Harborview Medical Center, Seattle, WA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01068522    
Other Study ID Numbers: 33888-B
1R01NS058302 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2010    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by University of Washington:
Intracranial pressure
Intracranial pressure monitoring
Head injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System