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

NCT01068522 | Unknown Phase 3 DMC

• 2 other identifiers: 33888-B1R01NS058302
• Study Type: interventional
• Target: 324
• Locations: 2 countries
• Sites: 6

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).

Conditions

Traumatic Brain Injury; Brain Injuries

Keywords

Intracranial pressure; Intracranial pressure monitoring; Head injury

Outcome Measures

Primary Outcomes (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.

  6 months

Study Arms (2)

ICP monitoring

EXPERIMENTAL

Care based upon intracranial pressure.

Device: Parenchymal Intracranial pressure monitor

Usual Care

ACTIVE COMPARATOR

Treatment based on clinical and imaging without intracranial pressure monitoring.

Other: Treatment based on clinical and imaging observations

Interventions

Parenchymal Intracranial pressure monitor DEVICE

Treatment based on readings from Parenchymal intracranial pressure monitor.

Also known as: Integra Life Sciences Camino Intracranial Monitor

ICP monitoring

Treatment based on clinical and imaging observations OTHER

Treatment based on clinical and imaging observations.

Usual Care

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (6)

Hospital Viedma

Cochabamba, Bolivia

Location

Hospital Japones

Santa Cruz de la Sierra, Bolivia

Location

Hospital San Juan de Dios

Santa Cruz de la Sierra, Bolivia

Location

Hospital San Juan de Dios

Tarija, Bolivia

Location

Hospital de Especialidades Eugenio Espejo

El Ángel, Ecuador

Location

Hospital Luis Vernaza

Guayaquil, Ecuador

Location

Related Publications (1)

• Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W, Petroni G, Lujan S, Pridgeon J, Barber J, Machamer J, Chaddock K, Celix JM, Cherner M, Hendrix T; Global Neurotrauma Research Group. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012 Dec 27;367(26):2471-81. doi: 10.1056/NEJMoa1207363. Epub 2012 Dec 12.

  PMID: 23234472 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Randall M Chesnut, MD

  University of Washington, Harborview Medical Center, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 15, 2010
• Study Start: July 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: March 1, 2013
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

BO (4); EC (2)