Safety and Outcomes of Acute Revascularization Treatment in COVID Patients: an International Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,128
- 试验地点
- 1
- 主要终点
- Rate of symptomatic intracranial hemorrhage
研究概览
简要总结
Case-series and cohort studies have shown the feasibility of reperfusion therapies in patients with ischemic stroke and COVID-19, but due to the absence of a contemporary control group of non-COVID-19 patients, small sample size or lack of long-term outcome assessment, concerns regarding safety and efficacy of these treatments remain to be clarified. Taking into account its limitations, some studies documented higher rates of endovascular treatment complications such as clot fragmentation with distal embolization and vessel re-oclusion, to be more difficult to achieve recanalization after endovascular treatment, and higher rates of any intracerebral hemmorhage.
The investigators aim is to assess in a large, multicenter and international cohort, the safety and outcomes of acute reperfusion therapies in patients with ischemic stroke and COVID-19, by comparison with a contemporary control group of patients with ischemic stroke and without COVID-19 from the same centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Consecutive ischemic stroke patients receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment) up to 24 hours since last time since well, and according to local treatment criteria
- •From 1st of March 2020 (for Chinese Centers from 1st January 2020)
排除标准
- •Patients without a PCR- or antigen test within the first 7 days after treatment
- •Patients with nosocomial SARS-CoV-2 infection after receiving acute recanalization treatment - PCR- or antigen test becoming positive more than 7 days after treatment
- •Patients with "Suspect/ probable case of SARS-CoV-2 infection" according to the World Health Organization definition
- •Symptomatic cases of SARS-CoV-2 infection with symptoms resolution more than 7 days before treatment
- •Asymptomatic cases of SARS-CoV-2 infection with treatment performed more than 10 days after first positive test for SARS-CoV-2
结局指标
主要结局
Rate of symptomatic intracranial hemorrhage
时间窗: 36 hours
Symptomatic parenchymal hemorrhagic transformation according to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition, and/or subarachnoid hemorrhage with ≥4-point worsening in NIHSS (National Institute of Health Stroke Scale)
次要结局
- Rate of first pass effect during endovascular treatment(End of procedure)
- Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion)(End of procedure)
- 3-month mortality(3 months)
- Rate of any hemorrhagic transformation(36 hours)
- 3-month modified Rankin Scale (mRS)(3 months)
- Number of passes during endovascular treatment(End of procedure)
- 3-month favorable outcome(3 months)
- Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction)(End of procedure)
- Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] ≥2b)(End of procedure)
- Delta NIHSS (National Institute of Health Stroke Scale) at 24 hours(24 hours)
研究者
Joao Pedro Marto
João Pedro Marto
Centre Hospitalier Universitaire Vaudois