COVID-19 Brain Injury

Severe Neurologic Injury Outcomes During COVID-19 Crisis

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Traumatic Brain Injury; Subarachnoid Hemorrhage; Hemorrhagic Stroke; Intracerebral Hemorrhage; Status Epilepticus; Sars-CoV2; Severe Neurologic Injury

Detailed Description

COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As resources become more limited and we have to triage /ration ventilators, neurologically injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no ventilator care due to their perceived or actual prognosis. This may lead to increased rates of withdrawal of care and mortality. Some neurologically injured ICU patients with respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are completely unknown. Capturing data on the prevalence of limitation of care and prognosis in this patient population will provide important information towards ongoing efforts in patient care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the expected strain on ICU resources and limitations in research in ICUs during COVID 19 pandemic, data capture/study design must be targeted and pragmatic. This study is designed to answer the most basic and important questions while minimizing the burden of data collection on already overloaded providers.

This study design is comprised of two components: Component 1- Prospective cohort prevalence study captures data related to treatments offered, limitations of care and patient outcome in 5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study captures the same data elements in the same patient populations during the 3 months prior COVID 19 pandemic (Sept - Dec, 2019).

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

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

Patients with 5 select primary neurological diagnoses (Acute Ischemic Stroke, Acute Intracerebral Hemorrhage, Acute Subarachnoid Hemorrhage, Acute Traumatic Brain Injury, Status Epilepticus) requiring ICU care

Description

Inclusion Criteria:

• Patients greater than or equal to 18
• Patients who require critical care with primary diagnoses of: Acute ischemic stroke (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH), acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring critical care

Exclusion Criteria:

• Patients under the age of 18 years old
• Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only (CMO) status prior to acute hospitalization
• Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils, catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-hospital Mortality	At hospital discharge, approximately 1 month
30-day mortality	30 days post-hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limitations of patient care- Frequency of care not being provided	Care treatment such as ventilator use, intubation, and/or tracheostomy	During In-hospital course, up to 1 month
Limitations of patient care- Conversion of DNR/DNI/CMO status		During In-hospital course, up to 1 month

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Sherry H Chou, MD, MSc, University of Pittsburgh

Publications and helpful links

Helpful Links

• NCC COVID-19 Research Opportunities

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Seizures; Stroke; Ischemic Stroke; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke; Status Epilepticus
• Other Study ID Numbers: STUDY20030201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No