Early Diagnosis of Mortality Using Admission CT Perfusion in Severe Traumatic Brain Injury Patients (ACT-TBI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- The primary outcome is a binary outcome of mortality ('dead') or survival ('not-dead') in the first 48 hours of hospital admission.
研究概览
简要总结
Background: Severe traumatic brain injury (TBI) is a principal cause of post-injury hospitalization, disability, and death throughout the world. TBI is the leading cause of death and disability among young healthy people under 45 years of age and is predicted to be the most prevalent and costliest neurological condition in Canada through the year 2031.
TBI is commonly classified into mild, moderate, and severe categories using the Glasgow Coma Scale (GCS), with "severe TBI" defined as a GCS score ≤ 8. Severe TBI is a clinical emergency, during which the trauma team works swiftly to provide the appropriate care. Outcome assessment after TBI is complex and is influenced by pre-injury and injury factors as well as the patient's response at various stages of recovery. The first 48 hrs in hospital, despite being the most resource-intensive period, unfortunately result in the highest mortality. These patients are on life support at the time of their hospital admission and adequate and reliable clinical examination is impossible. Thus, patients receive treatment despite lack of a clear understanding of their prognoses.
Hypothesis: Admission Computed Tomographic Perfusion (CTP) can diagnose brain death reliably in severe TBI patients in early stage upon hospital admission, which is not recognised in the usual clinical practice due to inadequate reliable clinical examination. In a small prospective pilot study of 19 patients with severe TBI, admission CTP could predict early in hospital mortality with 75% sensitivity, 100% specificity, 100% positive predictive value (PPV) and 94% negative predictive value (NPV) and perfect inter-rater reliability (kappa=1). We propose ACT-TBI study to evaluate CTP as a triage tool to diagnose early mortality at the time of admission in patients with severe TBI.
Primary Objective: To validate admission CTP features of brain death, relative to the clinical examination outcome, for characterizing early in-hospital mortality.
Secondary objectives: To establish the safety and interrater reliability of admission CTP.
详细描述
Objectives of the ACT-TBI study:
In patients with severe TBI,
- To validate admission CTP features of brain death, relative to the clinical examination outcome, for characterizing early in-hospital mortality.
- To establish the safety and inter-rater reliability of features of brain death on admission CTP.
- To evaluate the determinants (age, sex, and GCS score) influencing the variability in response of CTP.
- To establish the usefulness of CTP in facilitating timely organ transplantation, if possible.
Research Design and Method The ACT-TBI study is a prospective, multi-centre, cohort study in patients with severe TBI and will be conducted in 4 different Canadian centres (Winnipeg, Ottawa, Montreal, and Halifax) over the next 4 years.
Those patients meeting eligibility criteria will be identified by a dedicated research nurse with the help of the trauma team at the time of hospital admission, with the ACT-TBI study protocol will be activated at the time of their first diagnostic imaging. A deferral of consent will be obtained like that in the pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Severe head injury with the activation of the trauma code
- •GCS score ≤ 8 after initial resuscitation
- •On mechanical respiratory ventilation at the time of imaging
排除标准
- •No known GCS after initial resuscitation
- •Known pregnancy
- •Known contraindication to CT contrast agent, e.g.,allergy or anaphylactic reaction
- •Known end-stage renal disease stage 4-5 (eGFR < 30 mL/min/1.73 m2)
结局指标
主要结局
The primary outcome is a binary outcome of mortality ('dead') or survival ('not-dead') in the first 48 hours of hospital admission.
时间窗: 48 hours
The primary outcome of this study is determining the mortality ('dead') or survival ('not-dead') in the first 48 hours of hospital admission using CTP.
次要结局
- In-hospital mortality at the end of hospital discharge.(6 months)
研究者
Jai Shankar
Professor
University of Manitoba