Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO (COPILOT): an Effectiveness Cluster Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Change in the time from triage assessment to thrombectomy puncture
研究概览
简要总结
Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.
详细描述
The COPILOT trial utilizes a cluster randomized crossover design within the Sistema de Salud Menonita (SSM) hospital network to evaluate if early detection of large vessel occlusion (LVO) stroke with a novel blood test can accelerate the time from triage assessment to thrombectomy puncture. It will unfold in three phases:
Phase 0 - Baseline Data Collection (3 months): Before the random allocation, all clusters undergo data collection on baseline characteristics and outcome measures to confirm/set a pre-intervention comparison ground. Phase 0 patients will receive the current standard of care. An interim analysis will check recruitment rates and explore the need for additional clusters for adequate study power.
Phase 1 - Intervention and Control (12 months): Clusters are randomized to either the intervention or control group, with the intervention arm implementing the LVOne test and the control arm continuing standard care without the LVOne test. Data analysts remain blinded to group allocation, while an interim analysis revisits recruitment and primary outcomes to assess whether additional clusters are required.
Phase 2 - Crossover (12 months): Clusters switch roles from Phase 1, allowing every cluster to experience both the intervention and control conditions, facilitating within-cluster comparisons. The nature of the intervention prevents the blinding of participants and staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The neuro-radiologist(s) who will read patient brain imaging and the expert stroke clinician(s) who will assign a clinical outcome (reference standard) will be blinded to the LVOne test results. Due to the nature of the LVOne and the management implications of a positive test, hospital clinicians will not be blinded to these results.
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 21 to 85 years old
- •Language: Speak and understand Spanish or English
- •Residence: Resident of Puerto Rico
- •Clinical presentation: Suspected acute stroke
- •Time of presentation: Monday to Friday, between 8:00 a.m. and 4:00 p.m.
- •Time of symptom onset: symptoms are known to have begun within the last 6 hours, OR last known to be well between 6 and 18 hours ago, confirmed by a reliable witness or healthcare professional
排除标准
- •Previous healthcare encounter:
- •Already assessed at another hospital, and ambulance admission is a transfer for continuing care OR
- •Received thrombolysis therapy before consent (e.g., tPA, alteplase)
- •Medical History: diagnosed with any of the following in the past 4 weeks: deep vein thrombosis (DVT), pulmonary embolism (PE), arterial embolism, stroke, transient ischemic attack (TIA), long bone fracture, major trauma, surgery under general anesthesia, or head injury requiring hospital admission within the last 4 weeks.
- •Modified Rankin Scale: Pre-stroke mRS ≥ 3
- •The patient is a pregnant woman
- •The patient is under legal custody or deprived of liberty in penitentiary institutions
- •The patient is unable to provide informed consent on their own and whose authorized legal representatives are unavailable in person or by telephone during recruitment
研究组 & 干预措施
Standard of Care
Participants will receive the current diagnostic standard of care.
干预措施: Diagnostic standard of care (Diagnostic Test)
LVOne Test
Participants will receive the LVOne test alongside the current standard of care.
干预措施: Diagnostic standard of care (Diagnostic Test)
LVOne Test
Participants will receive the LVOne test alongside the current standard of care.
干预措施: LVOne Test (Diagnostic Test)
结局指标
主要结局
Change in the time from triage assessment to thrombectomy puncture
时间窗: 24 hours
The difference in time from the participant triage assessment to thrombectomy puncture.
次要结局
- Time from HUB hospital triage assessment to LVOne test in intervention(24 hours)
- Time from HUB hospital triage assessment to thrombectomy puncture(24 hours)
- Thrombectomy rate (proportion of treated LVO)(24 hours)
- Length of hospital stay(From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days)
- Time from spoke hospital triage assessment to LVOne test in intervention(24 hours)
- Length of ICU stay(From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days)
- Diagnostic accuracy for LVO detection(At the time of initial assessment and confirmed by diagnostic imaging within 24 hours)
- Diagnostic accuracy for intracerebral hemorrhage detection(At the time of initial assessment and confirmed by diagnostic imaging within 24 hours)
- Modified Rankin Scale (mRS)(At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months)
研究者
Juan Vicenty
MD
University of Puerto Rico