MedTrace Logo

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

NCT01068522 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2012-11-01

No results posted yet for this study

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

Interventions

DEVICE

Parenchymal Intracranial pressure monitor

Treatment based on readings from Parenchymal intracranial pressure monitor.

OTHER

Treatment based on clinical and imaging observations

Treatment based on clinical and imaging observations.

Sponsors & Collaborators

Principal Investigators

  • Randall M Chesnut, MD · University of Washington, Harborview Medical Center, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-04-30
Completion
2013-03-31

Countries

  • Bolivia
  • Ecuador

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068522 on ClinicalTrials.gov