Global Impact of the COVID 19 Pandemic on Stroke Care, Cerebral Venous Thrombosis, and Subarachnoid Hemorrhage
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ClinicalTrials.gov Identifier: NCT04934020 |
Recruitment Status :
Completed
First Posted : June 22, 2021
Last Update Posted : November 16, 2022
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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
4) 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
Condition or disease | Intervention/treatment |
---|---|
Stroke | Other: Pre-pandemic stroke related metrics Other: Stroke related metrics during the pandemic |

Study Type : | Observational |
Actual Enrollment : | 345089 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Global Impact of the COVID 19 Pandemic on Stroke Care: 1-year Follow-up Study |
Actual Study Start Date : | April 25, 2021 |
Actual Primary Completion Date : | October 31, 2021 |
Actual Study Completion Date : | December 9, 2021 |

- Other: Pre-pandemic stroke related metrics
De-identified data from selected stroke metrics identified by ICD-10 codes will be abstracted from medical records of stroke patients in about 200 stroke centers in 6 continents.
- Other: Stroke related metrics during the pandemic
De-identified data from selected stroke metrics identified by ICD-10 codes will be abstracted from medical records of stroke patients in about 200 stroke centers in 6 continents.
- Trends in stroke metrics before and during the covid pandemic [ Time Frame: 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 [ Time Frame: 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.
- Severity of subarachnoid hemorrhage presentation [ Time Frame: 12 months ]The severity of presentation of patients with subarachnoid hemorrhage will be assessed using the Hunt Hess Grade which is a graded scale used to predict the rate of mortality based solely on the clinical features seen in a patient presenting with an aneurysmal subarachnoid hemorrhage. There are grades 0 to 6: 0=Unruptured aneurysm without symptoms; 1=Asymptomatic or minimal headache with slight nuchal rigidity; 1a=No acute meningeal or brain reaction but with fixed neurological deficit; 2=Moderate to severe headache, nuchal rigidity, no neurological deficits other than cranial nerve palsy; 3=Drowsy, confused, or mild focal deficit; 4=stupor, moderate to severe hemiparesis, possible early decerebrate rigidity, and vegetative disturbances; 5=Deep coma, decerebrate rigidity, moribund. Higher grades are correlated with greater severity.
- Subarachnoid hemorrhage clinical outcome [ Time Frame: 12 months ]Clinical outcome will be assessed by rates of in-hospital mortality and discharge to hospice abstracted from medical records.
- Cerebral venous thrombosis (CVT) [ Time Frame: March 2019 to February 2020, March 2020 to December 2020, January 2021 to May 31, 2021 ]Morality, thrombocytopenia (<150K) related to CVT will be assessed prior to, and during the COVID-19 pandemic, and during the vaccine roll-out phase
- CVT related thrombocytopenia [ Time Frame: March 2019 to February 2020, March 2020 to December 2020, January 2021 to May 31, 2021 ]Thrombocytopenia related to CVT will be assessed pre-COVID, during COVID, and post vaccine roll-out phases

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Received stroke related care during the study period in one of the stroke centers across 6 continents
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04934020
United States, Georgia | |
Grady Memorial Hospital, Emory University | |
Atlanta, Georgia, United States, 30303 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Thanh N Nguyen | Boston Medical Center | |
Principal Investigator: | Raul G Nogueira, MD | Grady Memorial Hospital, Emory University |
Other Publications:
Responsible Party: | Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT04934020 |
Other Study ID Numbers: |
NHSR-1 |
First Posted: | June 22, 2021 Key Record Dates |
Last Update Posted: | November 16, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ischemic stroke hospitalizations TIA hospitalizations Intracranial hemorrhage hospitalizations Cerebral venous thrombosis hospitalizations Aneurysmal subarachnoid hemorrhage hospitalizations |
Mechanical thrombectomy Intravenous thrombolysis Ruptured aneurysm endovascular coiling Ruptured aneurysm clipping |
COVID-19 Stroke Subarachnoid Hemorrhage Venous Thrombosis Hemorrhage Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Thrombosis Embolism and Thrombosis Respiratory Tract Infections |
Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Intracranial Hemorrhages Metronidazole Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents |