TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- mRS score after 90 days for AIS patients
研究概览
简要总结
Should we prioritize thrombectomy or thrombolysis in acute stroke? Finding the answer to this question will improve treatment and outcome for stroke patients only by changing triage and transportation. And it will have implications for stroke patients around the world.
The investigators propose a national investigator-driven, multi-center, randomised single-blinded clinical trial to investigate which treatment strategy is superior in patients with acute stroke and suspected large vessel occlusion (LVO): direct transport to a comprehensive stroke center for early endovascular therapy (EVT) or to a primary stroke center for early IV thrombolysis followed by secondary transport to a comprehensive stroke center for EVT if needed.
Effective reperfusion therapy marks a new era within stroke medicine and has been driving major changes in the organization of care within the last decade. Timely thrombolysis and/or EVT in acute ischemic stroke is a key factor for improved outcome. Major stroke occur in 25% of all cases and is caused by LVO. Major strokes have approximately 60% risk of severe disability or death at three months if not treated. EVT is superior to thrombolysis in strokes caused by a LVO, but EVT is only performed in specialized centers due to the complexity of the treatment and need for skilled neurointerventionalists.
A simple stroke severity score has been developed, that can identify most patients with LVO in the pre-hospital setting. This enables selection of patients with a suspected LVO to be transported without delay directly to a comprehensive stroke center for EVT while potentially bypassing a nearer primary stroke center for IV-thrombolysis.
Study results will have major impact of future acute stroke treatment and organization.
详细描述
Project description In the new area of reperfusion therapy for acute ischemic stroke (AIS) a major question has emerged: Should the Emergency Medical Service take the patient to the nearest primary stroke center (for fast thrombolysis) or should they bypass the primary stroke center and take the patient directly to a comprehensive stroke center with endovascular capabilities? We propose a randomized controlled single-blind trial to explore this worldwide clinical dilemma.
Objective To determine if direct transport to a comprehensive stroke center improves outcome for patients with suspected large vessel occlusion (LVO) that occur in the catchment area of a primary stroke center without potentially harming patients who only need thrombolysis.
Hypothesis
The guidelines tell us to admit a stroke patient to the nearest stroke hospital. The investigators wish to perform the study because we believe that in case of LVO, direct transport to a comprehensive stroke center is a better strategy. The investigators hypothesize that:
- A symptom based triage strategy in the catchment area of the primary stroke center results in net benefit for patients with AIS.
- AIS patients with a LVO occurring in a primary stroke center catchment area will have better clinical outcome at 90 days if they are transported directly to a comprehensive stroke center.
- AIS patients without LVO at admission might be subjected to a longer transport to a comprehensive stroke center and a longer delay to IV thrombolysis, but this will not translate into a poorer prognosis for patients with AIS.
- Patients suspected to have LVO who turn out to have ICH or stroke mimics after imaging on admission will not be harmed from being randomized to alternative pre-hospital transport strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Single-blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of acute stroke
- •No contraindication for IV thrombolysis
- •Stroke occurring ("pick up" place) in catchment area of a primary stroke center
- •The patient has Pre-hospital Acute Stroke Severity (PASS) score ≥2
- •Pre-stroke modified Rankin Score 0-2 (meaning living independently.)
- •Feasible to start IV-thrombolysis within 4.5 hours at CSC
排除标准
- •Known diagnosis of epilepsy
- •Medical condition and no signs of stroke (e.g. hypoglycemia)
- •In-hospital strokes
- •Life expectancy of less than 1 year.
- •Exclusion criteria for the analysis of the ischemic patients (to be determined after admission at stroke center)
- •Imaging showing ICH
- •Stroke mimics
结局指标
主要结局
mRS score after 90 days for AIS patients
时间窗: 90 days
Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all patients ending with diagnosis of AIS.
次要结局
- Severe dependency or death after 90 days for AIS patients treated with EVT(90 days)
- Length of stay at CSC for all patients withpot LVO(1 week)
- mRS score after 90 days (shift analysis) for all randomized.(90 days)
- mRS score after 90 days (shift analysis) for patients with hemorrhagic stroke(90 days)
- mRS score after 90 days (shift analysis) for patients with stroke mimics(90 days)
- Severe dependency or death after 90 days in patients with hemorrhagic stroke(90 days)
- Times (from onset, pick-up and arrival)to IV thrombolysis for patients treated with IV thrombolysis only.(1 day)
- mRS score ≤2 (independent) after 90 days for AIS patients treated with EVT(90 days)
- Successful re-perfusion in EVT treated(1 day)
- mRS score after 90 days (shift analysis) for AIS patients without LVO(90 days)
- Times (from onset, pick-up and arrival) to groin puncture for patients treated with EVT(1 day)