Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 351
- 试验地点
- 3
- 主要终点
- Proportion of participants having a CT head scan from biomarker positive
研究概览
简要总结
This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging.
In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).
详细描述
The Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT) study aims to determine whether immediate access to blood biomarker data can help doctors decide when a CT scan is necessary for patients with mild traumatic brain injury (mTBI). The study will also explore how biomarker data influences clinical outcomes, such as hospital stay duration, costs, and recovery. Additionally, it will identify specific patient groups where biomarker results may alter imaging decisions, assess the ability of biomarkers to predict worsening symptoms and develop predictive models to improve the accuracy of these tests compared to CT scans.
The study will enroll adults presenting with suspected mild traumatic brain injury (mTBI) in the emergency department at Grady Memorial Hospital. Minors, pregnant individuals, wards of the state, prisoners, and those with cognitive impairments will not be enrolled.
Participants will undergo blood-based biomarker testing upon ED presentation. Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.
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
- •Adults aged 18 years and older
- •Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury
- •No prior head imaging for the same incident
- •Presenting within 24 hours of onset of injury
排除标准
- •Patients with penetrating head injury
- •History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months)
- •Need for emergent surgical intervention for brain or alternate body organ injury
- •Need for emergent bedside procedures for hemodynamic or orthopedic stabilization
- •Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.
研究组 & 干预措施
Blinded Biomarker Group
Biomarker results are not disclosed during the decision-making process for cranial imaging.
干预措施: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT (Diagnostic Test)
Published Biomarker Group
Biomarker results are provided to the ED provider immediately and before the decision to order a head CT is made. A print-out of the results will be handed to the provider or uploaded to the epic platform.
干预措施: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT (Diagnostic Test)
结局指标
主要结局
Proportion of participants having a CT head scan from biomarker positive
时间窗: During hospital admission (average 15 days).
The impact of biomarker results will be measured by the decision to obtain CT head imaging for patients presenting with mild TBI.
次要结局
- Length of hospital stay(Hospital admission (average 15) days.)
- Glasgow Outcome Scale-Extended (GOS-E)(6 months after hospital discharge)
- Glasgow Outcome Scale-Extended (GOS-E)(6 and 12 months after hospital discharge)
- Length of hospital stay(Hospital admission (average 15) days.)
- Number of participants with intracranial findings predicted by biomarker findings(Hospital admission (average 15) days.)
- Number of readmissions for TBI-related symptoms(up to 6 months after hospital discharge)
- Glasgow Outcome Scale-Extended (GOS-E)(6 months after hospital discharge)
研究者
Jonathan A. Grossberg
Professor of Surgery
Emory University