StrokeNCT07844109
Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.
A study testing GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS) and CT Head in people with Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS) and CT Head
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Sep 2027to 30 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Time from symptom onset/ Last well known time (≤ 24 hours)
- NIHSS ≥ 5
- Consent provided by patient/ next of kin
Who cannot join
- 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
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites
Christian Medical College and Hospital
Ludhiana, Punjab, 141008
Dr Ivy A Sebastian, 9999464986, ivy29cmc@gmail.com
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
Puducherry, Puducherry, 605006
Dr Manu Ayyan, 9846556133, manuayyan@hotmail.com
About this study
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.
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).
Read more
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)
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS), CT Head
- Keywords
- Acute stroke, Ischemic stroke, Intracerebral hemorrhage, Prehospital stroke triage, GFAP, D-Dimer, CEREBO, Near-Infrared Spectroscopy, PREDICT Assessment Model, Point-of-Care Testing, Stroke classification, Stroke diagnosis
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS)Diagnostic test
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 HeadDiagnostic test
Standard care CT head imaging
| Study group | Role | What they receive |
|---|---|---|
| PREDICT Assessment Model | Experimental | 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. Receives: Diagnostic Test: GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS) |
| Standard Care | Active comparator | 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. Receives: Diagnostic Test: CT Head |
What is being measured
The primary outcome is the main question the study is designed to answer.
PREDICT assessment model
(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH >90% using PREDICT model.
Measured: 30 mins
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.
Measured: 30 mins
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.
Measured: 30 mins
Secondary outcomes (6)
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.
Measured: 2 years
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.
Measured: 2 years
Safety Metrics
Phase 1 Documentation of adverse events related to the testing procedure. Fewer events indicate a better outcome.
Measured: 2 years
modified Rankin Scale
Phase 2 Functional outcome at 90 days Lower score (0-3) indicates good outcome
Measured: 90 days
In-hospital mortality
Phase 2 In-hospital mortality. Lesser mortality indicates better outcome
Measured: 7 days
Adverse events
Phase 2 Incidence of adverse events (e.g., symptomatic ICH). Lesser events indicate better outcome.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Sep 2027 (estimated)
- Primary completion30 Aug 2031 (estimated)
- Study completion30 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I Suspected stroke patients will undergo CEREBRO NIRS assessment during ambulance transport or upon arrival in the CMC, Ludhiana emergency department. CT imaging will serve as the gold standard reference. Phase II Ambulance services within the catchment areas of Christian Medical College (CMC), Ludhiana and JIPMER, Puducherry will be randomized into two parallel groups: an intervention group using the PREDICT Assessment Model (GFAP/D-Dimer point-of-care testing plus CEREBO Near-Infrared Spectroscopy) and a control group receiving standard prehospital stroke care and transport for CT-based diagnosis. Randomization will occur centrally at the command center using a computer-generated randomization sequence with allocation concealment.
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Sponsor
- Investigators
- Dr Jeyaraj D Pandian, MD DM, Principal investigator, Christian Medical College and Hospital, Ludhiana, IndiaDr Ivy A Sebastian, Principal investigator, Christian Medical College and Hospital, Ludhiana, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844109
- Sponsor's protocol ID
- PREDICT INDIA-EMS
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Berkowitz AL. Managing acute stroke in low-resource settings. Bull World Health Organ. 2016 Jul 1;94(7):554-6. doi: 10.2471/BLT.15.162610. Epub 2016 Jun 2. No abstract available.
PubMed 27429496Abraham SV, Joy A, Sahu AK, Ravindra P, Dhar S, Teja R, Krishnan SV, Liu R, Rudd AG, Ford GA. Barriers to Effective Prehospital and Hyperacute Stroke Care in India: A Physician Perspective. J Emerg Trauma Shock. 2024 Jul-Sep;17(3):129-135. doi: 10.4103/jets.jets_156_23. Epub 2024 Aug 30.
PubMed 39552827Ma L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Munoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1. Epub 2023 May 25.
PubMed 37245517Palaniswami M, Yan B. Mechanical Thrombectomy Is Now the Gold Standard for Acute Ischemic Stroke: Implications for Routine Clinical Practice. Interv Neurol. 2015 Oct;4(1-2):18-29. doi: 10.1159/000438774. Epub 2015 Sep 18.
PubMed 26600793Ren C, Kobeissy F, Alawieh A, Li N, Li N, Zibara K, Zoltewicz S, Guingab-Cagmat J, Larner SF, Ding Y, Hayes RL, Ji X, Mondello S. Assessment of Serum UCH-L1 and GFAP in Acute Stroke Patients. Sci Rep. 2016 Apr 14;6:24588. doi: 10.1038/srep24588.
PubMed 27074724Ramos-Pachon A, Lopez-Cancio E, Bustamante A, Perez de la Ossa N, Millan M, Hernandez-Perez M, Garcia-Berrocoso T, Cardona P, Rubiera M, Serena J, Ustrell X, Garces M, Terceno M, Davalos A, Montaner J. D-Dimer as Predictor of Large Vessel Occlusion in Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):852-858. doi: 10.1161/STROKEAHA.120.031657. Epub 2021 Feb 10.
PubMed 33563016Kalra LP, Khatter H, Ramanathan S, Sapehia S, Devi K, Kaliyaperumal A, Bal D, Sebastian I, Kakarla R, Singhania A, Rathore S, Klinsing S, Pandian JD, Foerch C. Serum GFAP for stroke diagnosis in regions with limited access to brain imaging (BE FAST India). Eur Stroke J. 2021 Jun;6(2):176-184. doi: 10.1177/23969873211010069. Epub 2021 May 11.
PubMed 34414293Gaude E, Murphy D, Gerstl JVE, Kappel AD, Dmytriw AA, Nawabi NLA, Izzy S, Guardia REA, Vicenty-Padilla JC, Gropen T, Patel NJ, Liebeskind DS, Siddiqui AH, See AP, Aziz-Sultan MA, Bernstock JD. Detection of GFAP and D-Dimer in a Point-of-Care Test for Large Vessel Occlusion Ischemic Stroke. Stroke Vasc Interv Neurol. 2025 Jan 11;5(2):e001559. doi: 10.1161/SVIN.124.001559. eCollection 2025 Mar.
PubMed 41573178
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07844109
- Acronym / sponsor ID
- PREDICT INDIA-EMS
- Conditions
- Stroke
- Keywords
- Acute stroke, Ischemic stroke, Intracerebral hemorrhage, Prehospital stroke triage, GFAP, D-Dimer, CEREBO, Near-Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 30 Aug 2031 (estimated)
- Study completion
- 30 Aug 2031 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I Suspected stroke patients will undergo CEREBRO NIRS assessment during ambulance transport or upon arrival in the CMC, Ludhiana emergency department. CT imaging will serve as the gold standard reference. Phase II Ambulance services within the catchment areas of Christian Medical College (CMC), Ludhiana and JIPMER, Puducherry will be randomized into two parallel groups: an intervention group using the PREDICT Assessment Model (GFAP/D-Dimer point-of-care testing plus CEREBO Near-Infrared Spectroscopy) and a control group receiving standard prehospital stroke care and transport for CT-based diagnosis. Randomization will occur centrally at the command center using a computer-generated randomization sequence with allocation concealment.
| Arm | Type | Receives |
|---|---|---|
| PREDICT Assessment Model | Experimental | Diagnostic Test: GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS)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. |
| Standard Care | Active comparator | Diagnostic Test: CT HeadAmbulances 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | PREDICT Assessment Model |
| CT HeadStandard care CT head imaging | Diagnostic test | Standard Care |
Primary outcome
PREDICT assessment model
Time frame: 30 mins
(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH >90% using PREDICT model.
Time for Device Application by Paramedics
Time frame: 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.
Treatment initiation
Time frame: 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.
6 secondary outcomes
Inter-Center Variability
Time frame: 2 years
Correlation with Gold Standard
Time frame: 2 years
Safety Metrics
Time frame: 2 years
modified Rankin Scale
Time frame: 90 days
In-hospital mortality
Time frame: 7 days
Adverse events
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Results publication: PubMed 27429496Berkowitz AL. Managing acute stroke in low-resource settings. Bull World Health Organ. 2016 Jul 1;94(7):554-6. doi: 10.2471/BLT.15.162610. Epub 2016 Jun 2. No abstract available.
- Results publication: PubMed 39552827Abraham SV, Joy A, Sahu AK, Ravindra P, Dhar S, Teja R, Krishnan SV, Liu R, Rudd AG, Ford GA. Barriers to Effective Prehospital and Hyperacute Stroke Care in India: A Physician Perspective. J Emerg Trauma Shock. 2024 Jul-Sep;17(3):129-135. doi: 10.4103/jets.jets_156_23. Epub 2024 Aug 30.
- Results publication: PubMed 37245517Ma L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Munoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1. Epub 2023 May 25.
- Results publication: PubMed 26600793Palaniswami M, Yan B. Mechanical Thrombectomy Is Now the Gold Standard for Acute Ischemic Stroke: Implications for Routine Clinical Practice. Interv Neurol. 2015 Oct;4(1-2):18-29. doi: 10.1159/000438774. Epub 2015 Sep 18.
- Results publication: PubMed 27074724Ren C, Kobeissy F, Alawieh A, Li N, Li N, Zibara K, Zoltewicz S, Guingab-Cagmat J, Larner SF, Ding Y, Hayes RL, Ji X, Mondello S. Assessment of Serum UCH-L1 and GFAP in Acute Stroke Patients. Sci Rep. 2016 Apr 14;6:24588. doi: 10.1038/srep24588.
- Results publication: PubMed 33563016Ramos-Pachon A, Lopez-Cancio E, Bustamante A, Perez de la Ossa N, Millan M, Hernandez-Perez M, Garcia-Berrocoso T, Cardona P, Rubiera M, Serena J, Ustrell X, Garces M, Terceno M, Davalos A, Montaner J. D-Dimer as Predictor of Large Vessel Occlusion in Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):852-858. doi: 10.1161/STROKEAHA.120.031657. Epub 2021 Feb 10.
- Results publication: PubMed 34414293Kalra LP, Khatter H, Ramanathan S, Sapehia S, Devi K, Kaliyaperumal A, Bal D, Sebastian I, Kakarla R, Singhania A, Rathore S, Klinsing S, Pandian JD, Foerch C. Serum GFAP for stroke diagnosis in regions with limited access to brain imaging (BE FAST India). Eur Stroke J. 2021 Jun;6(2):176-184. doi: 10.1177/23969873211010069. Epub 2021 May 11.
- Results publication: PubMed 41573178Gaude E, Murphy D, Gerstl JVE, Kappel AD, Dmytriw AA, Nawabi NLA, Izzy S, Guardia REA, Vicenty-Padilla JC, Gropen T, Patel NJ, Liebeskind DS, Siddiqui AH, See AP, Aziz-Sultan MA, Bernstock JD. Detection of GFAP and D-Dimer in a Point-of-Care Test for Large Vessel Occlusion Ischemic Stroke. Stroke Vasc Interv Neurol. 2025 Jan 11;5(2):e001559. doi: 10.1161/SVIN.124.001559. eCollection 2025 Mar.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Jeyaraj D Pandian, MD DM principal investigator
Christian Medical College and Hospital, Ludhiana, India
Dr Ivy A Sebastian principal investigator
Christian Medical College and Hospital, Ludhiana, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS) and CT Head in people with Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ivy A Sebastian (09592588138, ivy29cmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREDICT assessment model (time frame: 30 mins). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07844109, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.