Global Impact of the COVID 19 Pandemic on Stroke Care, Cerebral Venous Thrombosis, and Subarachnoid Hemorrhage

November 14, 2022 updated by: Boston Medical Center

Global Impact of the COVID 19 Pandemic on Stroke Care: 1-year Follow-up Study

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:

  1. ischemic stroke or transient ischemic attacks (TIA) hospitalizations
  2. intracranial hemorrhage hospitalizations
  3. cerebral venous thrombosis (CVT) hospitalizations (with or without thrombocytopenia)
  4. 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

Study Overview

Detailed Description

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

I63.0 Cerebral Infarction

I63.1 Cerebral infarction due to embolism of precerebral arteries

I63.2 Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries

I63.3 Cerebral infarction due to thrombosis of cerebral arteries

I63.4 Cerebral infarction due to embolism of cerebral arteries

I63.5 Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries

I63.8 Other cerebral infarction

I63.9 Cerebral infarction, unspecified

Intracranial Hemorrhage, ICD-10 Codes

I61 Nontraumatic intracerebral hemorrhage

I61.0 Nontraumatic intracerebral hemorrhage in hemisphere, subcortical

I61.1 Nontraumatic intracerebral hemorrhage in hemisphere, cortical

I61.2 Nontraumatic intracerebral hemorrhage in hemisphere, unspecified

I61.3 Nontraumatic intracerebral hemorrhage in brain stem

I61.4 Nontraumatic intracerebral hemorrhage in cerebellum

I61.5 Nontraumatic intracerebral hemorrhage, intraventricular

I61.6 Nontraumatic intracerebral hemorrhage, multiple localized

I61.8 Other nontraumatic intracerebral hemorrhage

I61.9 Nontraumatic intracerebral hemorrhage, unspecified

Cerebral Venous thrombosis, Codes

G08 Intracranial Phlebitis and Thrombophlebitis I63.6 Cerebral infarction due to cerebral venous thrombosis, nonpyrogenic I67.6 Nonpyrogenic Thrombosis of Intracranial Venous System O22.5 Cerebral venous thrombosis in pregnancy

Subarachnoid Hemorrhage, Codes

I60.0 Nontraumatic subarachnoid hemorrhage from carotid siphon and bifurcation

I60.1 Nontraumatic subarachnoid hemorrhage from middle cerebral artery

I60.2 Nontraumatic subarachnoid hemorrhage from anterior communicating artery

I60.3 Nontraumatic subarachnoid hemorrhage from posterior communicating artery

I60.4 Nontraumatic subarachnoid hemorrhage from basilar artery

I60.5 Nontraumatic subarachnoid hemorrhage from vertebral artery

I60.6 Nontraumatic subarachnoid hemorrhage from other intracranial arteries

I60.7 Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery

I60.8 Other nontraumatic subarachnoid hemorrhage

I60.9 Nontraumatic subarachnoid hemorrhage, unspecified

COVID19

UO7.1

Study Type

Observational

Enrollment (Actual)

345089

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital, Emory University
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

De-identified data from selected stroke metrics identified by ICD-10 codes from medical records of stroke patients in about 100 to 300 stroke centers in 6 continents will be analyzed.

Description

Inclusion Criteria:

  • Received stroke related care during the study period in one of the stroke centers across 6 continents

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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
March 2019 to February 2020, March 2020 to December 2020, January 2021 to May 31, 2021
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
March 2019 to February 2020, March 2020 to December 2020, January 2021 to May 31, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Thanh N Nguyen, Boston Medical Center
  • Principal Investigator: Raul G Nogueira, MD, Grady Memorial Hospital, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2021

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 9, 2021

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

June 20, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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