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)
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
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
Adult patients of any gender ≥18 years with clinically suspected stroke
Parallel
GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS)
Diagnostic testA 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.
CT Head
Diagnostic testStandard care CT head imaging
PREDICT assessment model
(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH \>90% using PREDICT model.
Time for Device Application by Paramedics
(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.
Treatment initiation
(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.
Inter-Center Variability
(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.
Correlation with Gold Standard
(Phase 1) Agreement between the PREDICT assessment model and the CT head scan diagnosis (the gold standard). More correlation indicates better outcome.
Safety Metrics
Phase 1 Documentation of adverse events related to the testing procedure. Fewer events indicate a better outcome.
modified Rankin Scale
Phase 2 Functional outcome at 90 days Lower score (0-3) indicates good outcome
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Christian Medical College and Hospital, Ludhiana, India
Lead sponsor
Indian Council of Medical Research
Collaborator
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