BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Diagnostic performance of the biomarker test
研究概览
简要总结
This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.
The study seeks to answer two primary questions:
- Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care.
- Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.
To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.
详细描述
GENERAL OBJECTIVE To assess the applicability and added value of a new clinical management pathway for patients with mild TBI presenting to the emergency department (ER), including the use of an in vitro diagnostic assay measuring the biomarkers GFAP and UCH-L1 in the serum, within the first 12 hours post-injury, to rule out the need for CT scan in mild TBI patients.
PRINCIPAL OBJECTIVE To evaluate the diagnostic performance of the VIDAS TBI (GFAP&UCH-L1) test in determining the need for CT-scan in patients with mild TBI admitted to the ER of Hospital 12 de Octubre.
To determine the safety of a management protocol including the use of the VIDAS GFAP&UCH-L1 test for patients with mTBI, in terms of complications or unforeseen neurological deterioration following the injury.
To estimate the reduction of CTs achieved using the biomarker test, by comparison with the management of TBI during the six months preceding the study (reference pathway).
METHODOLOGY The study will compare the different outcome measures between a historic group obtained 6 months before the initiation of the new management protocol and the group of patients admitted in the ER with a diagnosis of a mTBI after the initiation of the new bundle of care. Therefore the methodology of the study is an ambispective (or mixed) cohort study with historical controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •-All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
- •The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event.
- •Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.
- •At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.
- •a GCS between 15 and 13, at least 30 minutes after injury.
- •Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.
排除标准
- •· GCS 3-12 on admission
- •Age Below 18 years
- •Time of injury unknown
- •Time to injury exceeding 12 hours
- •Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
- •Penetrating head trauma
- •Patient with mechanical ventilation from the trauma scene or prehospital management
- •Venipuncture not feasible
结局指标
主要结局
Diagnostic performance of the biomarker test
时间窗: 12 hours after mild TBI
Sensitivity, specificity and NPV of the combined biomarker test to determine the presence of lesions on CT
Proportion (%) of CT scan prescribed in the ER over the period of the study for patients with mTBI
时间窗: 12 hours after mild TBI
Proportion of patients in whom a CT scan has been performed for screening of intracranial lesiones
次要结局
- Time spent in the ED(12 hours after mild TBI)
- Compliance with proposed algorithm(12 hours after mild TBI)
研究者
Alfonso Lagares Gómez-Abascal
Professor of Neurosurgery, Head of Department Neurosurgery
Hospital Universitario 12 de Octubre