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Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.
Sponsor: Christian Medical College and Hospital, Ludhiana, India
Summary
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)
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
232
Start Date
2027-09-01
Completion Date
2031-08-30
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
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.
CT Head
Standard care CT head imaging
Locations (2)
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
Puducherry, Puducherry, India
Christian Medical College and Hospital
Ludhiana, Punjab, India