跳至主要内容
临床试验/CTRI/2025/12/098611
CTRI/2025/12/098611尚未招募不适用

Health Technology Assessment (HTA) of point-of-care Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1(UCH-L1) biomarkers screening for optimizing triage of Traumatic Brain and Spinal Cord Injuries: A Cost-Effectiveness Study in Tertiary Care

Department of Health Research Ministry of Health and Family Welfare New Delhi1 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2026年1月31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
880
试验地点
1
主要终点
sensitivity, specificity, AUC

研究概览

简要总结

Traumatic Brain Injury and Spinal Cord Injury are major public health concerns that require rapid and accurate triage to reduce morbidity, mortality, and healthcare costs. Conventional diagnosis depends on computed tomography and magnetic resonance imaging, which increase resource use and radiation exposure in tertiary care. Point-of-care testing for Glial Fibrillary Acidic Protein and Ubiquitin C-terminal Hydrolase L1 has emerged as a promising biomarker-based tool for early identification of neurotrauma. This prospective, comparative, cohort study will evaluate the diagnostic accuracy and cost-effectiveness of point-of-care GFAP and UCHL1 testing compared with standard imaging-based triage among adults presenting within six hours of suspected traumatic brain or spinal cord injury. The study will measure diagnostic performance parameters such as sensitivity, specificity, positive and negative predictive values, and area under the ROC curve using CT or MRI findings as the reference standard. Cost-effectiveness will be assessed through incremental cost per quality-adjusted life year gained, together with reduction in imaging use, time to diagnosis, and hospital stay. Patient-centred outcomes including readmission rates and satisfaction will be recorded up to thirty days. The expected outcome is to establish evidence that biomarker-guided triage can safely and economically reduce unnecessary imaging, support faster decision making, and provide policy-relevant data for large-scale adoption of health technology assessment frameworks in emergency neurotrauma care.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adults aged more than 18 years Patients presenting to the emergency department within 6 hours of suspected TBI or SCI Patients with Glasgow Coma Scale (GCS) score between 9 to 15 (mild to moderate TBI) or suspected acute SCI based on clinical presentation.
  • Willingness to undergo rapid point-of-care GFAP and UCH-L1 screening.
  • Informed written consent provided by the patient or legal guardian.

排除标准

  • 未提供

结局指标

主要结局

sensitivity, specificity, AUC

时间窗: Time points is specific time at which the outcome will be assessed estimated at baseline, 4 weeks and 8 weeks

次要结局

未报告次要终点

研究者

发起方
Department of Health Research Ministry of Health and Family Welfare New Delhi
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

RENU TOMAR

GSVM Medical College Kanpur

研究点 (1)

Loading locations...

相似试验