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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- PREDICT assessment model
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is an open-label diagnostic medical device trial. Participants, ambulance personnel, investigators, and treating clinicians will be aware of the assigned intervention because the GFAP/D-Dimer point-of-care test and CEREBO-NIRS device are used during prehospital assessment.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS) (Diagnostic Test)
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.
干预措施: CT Head (Diagnostic Test)
结局指标
主要结局
PREDICT assessment model
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Inter-Center Variability(2 years)
- Correlation with Gold Standard(2 years)
- Safety Metrics(2 years)
- modified Rankin Scale(90 days)
- In-hospital mortality(7 days)
- Adverse events(90 days)