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Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.

2026年9月21日 更新者：Christian Medical College and Hospital, Ludhiana, India

Prehospital Rapid Evaluation and Detection in Cerebrovascular Triage: A Multicenter Study of Glial Fibrillary Acidic Protein Point of Care Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.

CEREBO is an ICMR award winning point-of-care (POC) adjunct CT scanning device for detecting brain hematomas in patients with head injury. The study aims to validate the diagnostic accuracy of the PREDICT Assessment Model (CEREBO-NIRS plus GFAP/D-Dimer POC Assay) in patients with suspected stroke. The study will be conducted as part of the Indian Council of Medical Research's National Health Research Priority (ICMR-NHRP) under the INDIA-EMS project using a two phase design.

PHASE I: Validation of a diagnostic accuracy and feasbility of PREDICT assessment model (a combined approach using GFAP/ D-dimer POC lateral flow assay plus CEREBO-NIRS technology).

Study Design: Prospective, Multicenter, Validation and Feasibility Study.

PHASE II: Pilot RCT to assess integration of the PREDICT assessment model into pre-hospital pathways.

Study Design: Pilot Randomized Controlled Trial (RCT) (Year 3-5)

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study, titled "Prehospital Rapid Evaluation and Detection in Cerebrovascular Triage: A Multicenter Study of Glial Fibrillary Acidic Protein Point-of-Care Testing and Handheld Near-Infrared Spectroscopy Technology (CEREBO) in India," aims to validate the PREDICT Assessment Model, which combines GFAP/D-Dimer point-of-care testing with handheld CEREBO Near-Infrared Spectroscopy (NIRS) technology for the rapid differentiation of ischemic stroke and intracerebral hemorrhage in the prehospital setting.

The study will be conducted under the Indian Council of Medical Research (ICMR) National Health Research Priority (NHRP) programme as part of the INDIA-EMS project and will use a two-phase design. Phase I is a prospective, multicenter validation and feasibility study involving patients with suspected acute stroke presenting by ambulance or directly to the emergency department. Participants will undergo clinical assessment, including BE-FAST and neurological assessment, finger-prick blood testing for GFAP/D-Dimer, and CEREBO-NIRS assessment. All participants will subsequently undergo standard diagnostic evaluation with a CT head scan, which will serve as the gold standard for stroke subtype classification. The diagnostic accuracy, feasibility, process times, and safety of the combined PREDICT Assessment Model will be evaluated.

Phase II will be a pilot randomized controlled trial evaluating the integration of the PREDICT Assessment Model into prehospital stroke pathways. Ambulance services within the catchment areas of CMC Ludhiana and JIPMER Puducherry will be randomized to intervention or control groups. In the intervention group, ambulance personnel will use GFAP/D-Dimer testing and CEREBO-NIRS technology to support prehospital stroke classification and triage, in coordination with the on-call stroke team. The control group will receive standard care, including transport to the hospital for CT-based diagnosis and subsequent treatment decisions.

The primary objective of the study is to validate the diagnostic accuracy and feasibility of the combined GFAP/D-Dimer and CEREBO-NIRS approach and to assess its potential impact on prehospital stroke triage. Phase II will additionally assess the effect of the intervention on the time from ambulance dispatch to initiation of stroke-specific treatment. Secondary outcomes include functional outcome at 90 days measured by the modified Rankin Scale, in-hospital mortality, and adverse events.

研究类型

介入性

注册 (估计的)

232

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 印度
    • Puducherry
      • Puducherry、Puducherry、印度、605006
        • Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
        • 接触：
    • Punjab
      • Ludhiana、Punjab、印度、141008
        • Christian Medical College and Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Phase 1

Inclusion criteria

  • Adult patients of any gender ≥18 years with clinically suspected stroke
  • Transported by ambulance or presenting directly to ED of participating hospitals
  • Time from symptom onset/ Lost known well time (within 24 hours)
  • Consent provided by patient/ next of kin

Exclusion criteria:

  • Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ICH in last 3 months, Diagnosis of brain tumour/SOL)
  • Patients with known medical condition with estimated life expectancy ≤ 3 months
  • Those refusing consent

Phase 2

Inclusion criteria:

  • Adult patients of any gender ≥18 years with clinically suspected stroke
  • Transported by ambulance to ED of participating hospitals
  • Time from symptom onset/ Last well known time (≤ 24 hours)
  • NIHSS ≥ 5
  • Consent provided by patient/ next of kin

Exclusion criteria:

  • Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ ICH in last 3 months, Diagnosis of brain tumour/ SOL)
  • Patients with known medical condition with estimated life expectancy ≤ 3 months
  • Those refusing consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：PREDICT Assessment Model

Ambulances in the intervention group will use the GFAP/D-Dimer point-of-care test and CEREBO Near-Infrared Spectroscopy (NIRS) technology to classify suspected acute stroke in the prehospital setting. Patients suspected of ischemic stroke and large vessel occlusion will be rapidly triaged to a comprehensive stroke centre, while patients suspected of intracerebral hemorrhage will receive stringent blood pressure control in the ambulance according to established protocols. Decision-making will be undertaken in conjunction with the on-call stroke team through the PREDICT App.
诊断测试：GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS)

A finger-prick blood sample will be obtained from patients with suspected acute stroke and tested using a GFAP/D-Dimer lateral flow assay. The test will provide rapid biomarker results to support differentiation between ischemic stroke and intracerebral hemorrhage in the prehospital setting and The handheld CEREBO-NIRS device will be applied non-invasively to the patient's scalp to detect intracranial hematoma by assessing asymmetry in near-infrared optical density. The findings will be recorded and used as part of the PREDICT Assessment Model for stroke subtype classification.
有源比较器：Standard Care

Ambulances in the control group will follow standard care procedures, including rapid transport of patients to the hospital for CT head imaging, followed by treatment decisions based on the CT findings.
诊断测试：CT Head

Standard care CT head imaging

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
PREDICT assessment model
大体时间：30 mins

(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH >90% using PREDICT model.
30 mins
Time for Device Application by Paramedics
大体时间：30 mins

(Phase 1) The time taken by paramedics/ ED personnel to apply the CEREBO NIRS device and obtain GFAP/D Dimer results. Lesser time indicates good outcome.
30 mins
Treatment initiation
大体时间：30 mins

(Phase 2) Time from Ambulance dispatch to initiation of stroke-specific treatment (Triage to Stroke ready centre or rapid BP control). Lesser time indicates better outcome.
30 mins

次要结果测量

结果测量
措施说明
大体时间
Inter-Center Variability
大体时间：2 years

(Phase 1) Comparison of diagnostic accuracy and feasibility metrics between CMC Ludhiana and JIPMER Puducherry to assess consistency across centres. More consistency indicates good outcome.
2 years
Correlation with Gold Standard
大体时间：2 years

(Phase 1) Agreement between the PREDICT assessment model and the CT head scan diagnosis (the gold standard). More correlation indicates better outcome.
2 years
Safety Metrics
大体时间：2 years

Phase 1 Documentation of adverse events related to the testing procedure. Fewer events indicate a better outcome.
2 years
modified Rankin Scale
大体时间：90 days

Phase 2 Functional outcome at 90 days Lower score (0-3) indicates good outcome
90 days
In-hospital mortality
大体时间：7 days

Phase 2 In-hospital mortality. Lesser mortality indicates better outcome
7 days
Adverse events
大体时间：90 days

Phase 2 Incidence of adverse events (e.g., symptomatic ICH). Lesser events indicate better outcome.
90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Christian Medical College and Hospital, Ludhiana, India

合作者

Indian Council of Medical Research

调查人员

  • 首席研究员：Dr Ivy A Sebastian、Christian Medical College and Hospital, Ludhiana, India
  • 首席研究员：Dr Jeyaraj D Pandian, MD DM、Christian Medical College and Hospital, Ludhiana, India

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年9月1日

初级完成 (估计的)

2031年8月30日

研究完成 (估计的)

2031年8月30日

研究注册日期

首次提交

2026年8月26日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月28日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PREDICT INDIA-EMS

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The study protocol does not currently specify a plan for sharing individual participant data (IPD) with other researchers. Any future IPD sharing will be considered in accordance with applicable ethical, regulatory, and data-protection requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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