NCT07844109Not yet recruiting
Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in 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.
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 1 Sept 2027
- Primary completion date
- 30 Aug 2031
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Diseases
- Stroke
- NCT number
- NCT07844109
What you commit to
- Study type: Interventional
- Planned participants: 232
- From 1 Sept 2027 to the primary completion date, 30 Aug 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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)
Other illness
- Patients with known medical condition with estimated life expectancy ≤ 3 months
- Patients with known medical condition with estimated life expectancy ≤ 3 months
Other
- Those refusing consent
- Phase 2
- Those refusing consent
Who the study is looking for
- 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
- 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
Criteria the registry did not label
- Phase 1
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Christian Medical College and Hospital Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.