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

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04934020
Collaborator
Emory University (Other)
345,089
2
7.5
172544.5
23034.3

Study Details

Study Description

Brief Summary

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

  1. 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 Phase
  • Other: Pre-pandemic stroke related metrics
  • Other: Stroke related metrics during the pandemic

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 Thromboplhlebitis I63.6 Cerebral infarction due to cerebral venous thrombosis, nonpyogenic I67.6 Nonpyogenic 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 Design

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 :
Apr 25, 2021
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Dec 9, 2021

Outcome Measures

Primary Outcome Measures

  1. Trends in stroke metrics before and during the covid pandemic [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.

  2. Vaccination impact on stroke metrics [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.

Secondary Outcome Measures

  1. Severity of subarachnoid hemorrhage presentation [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.

  2. Subarachnoid hemorrhage clinical outcome [12 months]

    Clinical outcome will be assessed by rates of in-hospital mortality and discharge to hospice abstracted from medical records.

  3. Cerebral venous thrombosis (CVT) [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

  4. CVT related thrombocytopenia [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Received stroke related care during the study period in one of the stroke centers across 6 continents
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grady Memorial Hospital, Emory University Atlanta Georgia United States 30303
2 Boston Medical Center Boston Massachusetts United States 02118

Sponsors and Collaborators

  • Boston Medical Center
  • Emory University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT04934020
Other Study ID Numbers:
  • NHSR-1
First Posted:
Jun 22, 2021
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2021