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

21 septembre 2026 mis à jour par: 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)

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

232

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Inde
    • Puducherry
      • Puducherry, Puducherry, Inde, 605006
        • Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
        • Contact:
    • Punjab
      • Ludhiana, Punjab, Inde, 141008
        • Christian Medical College and Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Test diagnostique: 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.
Comparateur actif: 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.
Test diagnostique: CT Head

Standard care CT head imaging

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PREDICT assessment model
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Inter-Center Variability
Délai: 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
Délai: 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
Délai: 2 years

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Christian Medical College and Hospital, Ludhiana, India

Collaborateurs

Indian Council of Medical Research

Les enquêteurs

  • Chercheur principal: Dr Ivy A Sebastian, Christian Medical College and Hospital, Ludhiana, India
  • Chercheur principal: Dr Jeyaraj D Pandian, MD DM, Christian Medical College and Hospital, Ludhiana, India

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2027

Achèvement primaire (Estimé)

30 août 2031

Achèvement de l'étude (Estimé)

30 août 2031

Dates d'inscription aux études

Première soumission

26 août 2026

Première soumission répondant aux critères de contrôle qualité

21 septembre 2026

Première publication (Réel)

28 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PREDICT INDIA-EMS

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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