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临床试验/NCT07397091
NCT07397091尚未招募不适用

ROUTINE INFLAMMATORY AND METABOLIC BIOMARKERS. Can They Predict a Positive Head CT in Paediatric Minor Traumatic Brain Injury?

Iuliu Hatieganu University of Medicine and Pharmacy7 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
800
试验地点
7
主要终点
Routine Biomarkers

研究概览

简要总结

Traumatic brain injury (TBI) poses significant strains on the paediatric population, for which the possible side effects of diagnostic imagistics could induce life-altering conditions. Routine inflammatory and metabolic biomarkers (complete blood count, C reactive protein, glucose) are frequently sampled in the paediatric patients admited within emergency departments, including the low-resource settings. This study aims to retrospectively document whether such routine blood biomarkers could predict a positive head CT scan and subsequently contribute to a prediction score, ment to enable more accurate decision on which minor TBI paediatric patients should be submitted to diagnotic imagistics.

详细描述

Epidemiology and Clinical Context Traumatic brain injury (TBI) is a significant global health concern, with an estimated paediatric global annual incidence of 226.4 cases per 100,000 children (1). The vast majority of these cases are categorized as non-severe, as up to 95% of head injuries in children are classified as minor or mild (mTBI) (1,2). Nevertheless, approximately one-third of paediatric patients experience persistent symptoms lasting beyond one month (3).

The current diagnostic gold standard remains non-contrast head Computed Tomography (CT). However, CT utilization carries significant associated risks, including exposure to ionizing radiation, high institutional costs, and the frequent necessity for procedural sedation (4). To mitigate these risks, clinical decision rules such as PECARN, CATCH, and CHALICE were developed to identify children at high risk for intracranial lesions. Despite these tools, most CT scans are still performed in cases of mTBI where the diagnostic yield is remarkably low (5).

As such, additional aiding tools have been investigated for refining the clinical decision rules regarding the paediatric mTBI patients in need of a CT scan.

Brain-Specific Biomarkers (GFAP, UCH-L1, S100B) In 2018, the US FDA authorized the first biomarkers (GFAP and UCH-L1) for predicting the necessity of CT scans in patients with minor TBI, supported by the ALERT-TBI trial (6). These markers serve as critical tools for both diagnosis and prognosis in neurotrauma (7).

GFAP (Glial Fibrillary Acidic Protein) is an astroglial protein that can predict positive CT findings in children with a sensitivity of 94% and a specificity of 47% (8). Its high sensitivity makes it an ideal "rule-out" marker.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

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

入选标准

  • Patients aged 0 to 18 years old presenting to the ED with mild traumatic brain injury (with or without cervical injury):
  • Mild TBI will be defined as GCS 14-15 or A (AVPU) upon admission
  • Patients underwent head CT
  • Routine blood biomarkers have been collected (complete blood count - CBC, biochemistry and/or (arterial) venos blood gases - (A)VBG).

排除标准

  • Patients with moderate (GCS 13-9 or V) or severe (GCS 8-3 or P,U) head trauma
  • Patients with associated trauma (limb/rib/pelvic fractures, organ injuries).

研究组 & 干预措施

Patients aged 0 to 18, mild TBI (GCS 14-15 or A on AVPU)

Patients aged 0 to 18 years old presenting to the ED with mild traumatic brain injury (with or without cervical injury):

  1. Mild TBI will be defined as GCS 14-15 or A (AVPU) upon admission
  2. Patients underwent head CT
  3. Routine blood biomarkers have been collected (complete blood count - CBC, biochemistry and/or (arterial) venos blood gases - (A)VBG).

结局指标

主要结局

Routine Biomarkers

时间窗: Upon ED admission for mTBI

1. CBC, the following items being mandatory: * WBC (white blood cells) and its subpopulations (NEU, LYM, MON) * NLR (neutrophiles-to-lymphocytes ratio) * PLR (platelets-to-lymphocyes ratio) * MLR (monocytes-to-lymphocytes ratio) * SII (systemic immune inflammation) index = NEU x PLT/ LYM * SIRI (systemic inflammatory response index) = NEU x MON/ LYM 2. C Reactive Protein 3. Glucose 4. (A)VBG - pH, lactate, base deficit, anion gap, bicarb

次要结局

  • Epidemiological Data(Upon ED admission for mTBI)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugenia-Maria Lupan-Muresan

Associated Professor

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (7)

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