Global Impact of the COVID 19 Pandemic on Stroke Care: 1-year Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345,089
- 试验地点
- 2
- 主要终点
- Trends in stroke metrics before and during the covid pandemic
研究概览
简要总结
A 1-year analysis of global selected stroke metric data will be conducted comparing the results during the Covid-19 pandemic to the pre-pandemic period. In most countries, this will correspond to March 1, 2020 to February 28, 2021. In some countries, the pandemic period would be adjusted for onset of case surge (i.e. China pandemic start date would begin earlier, i.e. January 2020). The specific metrics that will be analyzed include:
- ischemic stroke or transient ischemic attacks (TIA) hospitalizations
- intracranial hemorrhage hospitalizations
- cerebral venous thrombosis (CVT) hospitalizations (with or without thrombocytopenia)
- CVT in-hospital mortality
- aneurysmal subarachnoid hemorrhage hospitalizations 5) mechanical thrombectomy 6) intravenous thrombolysis 7) ruptured aneurysm endovascular coiling 8) ruptured aneurysm clipping. 9) aneurysmal subarachnoid hemorrhage admissions 10) SAH in-hospital mortality 11) SAH presentation by Hunt Hess Grade
详细描述
This is a retrospective, observational, cross-sectional, international study, across 6 continents, and estimated 100 stroke centers. The stroke metric diagnoses will be identified by their International Classification of Diseases version 10 (ICD-10) codes and/or classifications in stroke databases at participating centers. Aggregate monthly volume will be obtained from January 1, 2019 to May 31, 2021. For CVT related to COVID vaccine events, the study period extends until July 30, 2021
The primary hypotheses to be tested are:
- The overall 1-year volumes of the stroke metrics will be decreased compared to the prior year.
- With each subsequent COVID wave, there will be a decline in relation to the prior year volumes, as was seen with the first COVID-19 wave of the pandemic.
- A recovery or increase in stroke volume will occur during the vaccine roll-out phase on same metrics, compared to the immediately preceding period and/or compared to the same period one year prior.
- There will be a decline in mild clinical severity in the presentation of patients with subarachnoid hemorrhage as measured by the Hunt Hess Grade scale, parallel to the decline in mild severity of stroke admissions seen with the first wave of the pandemic. [Mild severity of presentation is defined as Hunt Hess Grade 0-2, moderate to severe is defined as Hunt Hess Grade 3-5.]
- There will be an increase of CVT diagnosis during the COVID-19 pandemic year, related either to heightened awareness of COVID-19 and thrombotic events, or related to reported associations of CVT and COVID-19.
The ICD codes utilized for the diagnosis are as follows:
Ischemic Stroke, ICD-10 Codes
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
- •Received stroke related care during the study period in one of the stroke centers across 6 continents
排除标准
- 未提供
结局指标
主要结局
Trends in stroke metrics before and during the covid pandemic
时间窗: 12 months
2- to 3-month trends in stroke metrics with COVID 2nd or 3rd waves in each country, using the Hopkins website to define waves of either the state or country with which the center is located https://coronavirus.jhu.edu/data/new-cases and compare to same period prior year A wave or phase is defined as a rising number of COVID-19 cases with a defined peak, followed by a decline in cases or trough period, in which transmission had decreased.
Vaccination impact on stroke metrics
时间窗: 12 months
The interaction between the vaccine roll-out phase on stroke metrics will be assessed, adjusted by country month in which 10% of population has been vaccinated with at least 1 dose using vaccine tracker data from https://ourworldindata.org/covid-vaccinations.
次要结局
- Subarachnoid hemorrhage clinical outcome(12 months)
- Severity of subarachnoid hemorrhage presentation(12 months)
- Cerebral venous thrombosis (CVT)(March 2019 to February 2020, March 2020 to December 2020, January 2021 to May 31, 2021)
- CVT related thrombocytopenia(March 2019 to February 2020, March 2020 to December 2020, January 2021 to May 31, 2021)