跳至主要内容
临床试验/NCT05855252
NCT05855252招募中不适用

PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury

Australian and New Zealand Intensive Care Research Centre9 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
9
主要终点
Glasgow outcome scale

研究概览

简要总结

Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.

详细描述

Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of death and long-term disability, particularly in young adults. In Australia and New Zealand, severe TBI accounts for over 700 intensive care unit (ICU) admissions per year. Approximately half of these patients will die or be severely disabled six months after their injury. The lifetime costs for the disabled survivors of TBI reach an estimated $1 billion annually. There are strong ethical, medical, social and health economic reasons to improve treatment and reduce disability in TBI.

TBI is a broad term for many different types of injuries to the brain. This study focuses on the most severe types of TBI that require hospital management and ICU care - moderate to severe TBI (m-sTBI). The fact that every patient with m-sTBI is different, has a different type of injury and is treated differently from hospital to hospital makes it very difficult to study m-sTBI and identify the most effective treatments for improving patient outcomes. At the moment, there is only a small amount of data on how m-sTBI patients are treated in the different hospitals in Australia and whether there are differences in outcomes associated with different approaches to m-sTBI management. Currently there is no central database for m-sTBI patients in Australia that can be used to compare different hospitals and track progress over time.

The first aim of PRECISION-TBI is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. High quality data about the initial injury (cause, severity and presence of factors that may make the injury worse), the early management of the patient (e.g. time to arrival at hospital), the surgical management of the patient (surgeries undertaken and monitoring probes utilised), the clinical management in ICU and neurological outcome after the injury will be collected. The main focus will be on the ICU management of m-sTBI so participating sites will be provided with computers and specialist software to collect accurate minute to minute data from brain monitors used to guide patient management in the ICU. Recovery at 6 months post-injury will be collected for all enrolled participants to understand how different injuries and treatments have affected long term patient outcomes.

The participating hospitals will also be provided with feedback on the characteristics of their m-sTBI patient population, the treatments that they are using and the outcomes for their patients. It will be possible for participating hospitals to compare each of these parameters with other similar hospitals and this will allow the identification of any factors that are strongly associated with improved patient outcomes. This will be provided over the course of at least 2 years, which will allow hospitals to track progress over time and identify how changes to management protocols and care systems may result in better outcomes for patients in this highly vulnerable group.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Clinical diagnosis of moderate to severe TBI
  • Insertion of invasive intra-cranial monitoring
  • Study inclusion within 48 hours of ICU admission

排除标准

  • Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
  • Advanced care directive or previously stated wish not to be included in research activities

结局指标

主要结局

Glasgow outcome scale

时间窗: At 6 months post-injury

Unfavourable outcome at 6 months post-injury (defined as a score of 4 or less on the 8-point extended Glasgow outcome scale)

次要结局

  • Mortality(Up to 6 months post-injury)
  • Hospital length of stay(Through study completion, an average of 1 year)
  • Intensive care Unit (ICU) length of stay(Through study completion, an average of 1 year)
  • EuroQol (EQ-5D five-level)(At 6 months post-injury)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

Loading locations...

相似试验