Traumatic Brain Injury in Latin America: Lifespan Analysis
试验速览
- 阶段
- 3 期
- 入组人数
- 324
- 试验地点
- 6
- 主要终点
- 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.
研究概览
简要总结
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).
详细描述
The objective of this application is to establish a network of Centers of Excellence within LABIC that will, in collaboration with U.S. partners, conduct research and training programs about TBI. To that end, this project will include scientific investigation and capacity building.
The primary focus for scientific investigation is to conduct a high quality randomized controlled trial addressing a question of critical importance to the management of TBI worldwide:
• Does the use of information provided by intracranial pressure (ICP) monitoring to direct treatment of patients with TBI improve medical practice and patient outcomes in a developing country? This trial will be conducted in three trauma centers in Bolivia, in which the infrastructures and practice patterns are optimal for strong internal validity, while at the same time the level of resources is representative of trauma care as practiced in the developing world.
The secondary focus for scientific investigation is to conduct a prospective study of TBI in seven trauma centers in Bolivia, Brazil, Argentina, Colombia, and Ecuador that represent the variation in access to and use of resources in the developing world. This study will address two questions of vital importance to management of TBI in developing countries:
- To what extent do the findings from the randomized trial about ICP monitoring in particular, and brain injury care in general, generalize to diverse populations of TBI patients in Latin America?
- What is the association between resources and outcomes from TBI in developing countries? To build capacity, we will provide education, equipment, and structure, and will foster the collaborations established during the pilot R21 phase of this project. Our commitment is that LABIC becomes completely independent as a research entity. At the end of the funding period LABIC constituents will be able to identify important research questions, design the research, write successful proposals for funding, carry out strong studies, analyze and interpret the data, submit successful publications to internationally recognized peer reviewed journals, and disseminate information across Latin America.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
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.
时间窗: 6 months
次要结局
未报告次要终点