COVID-19 Brain Injury
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ClinicalTrials.gov Identifier: NCT04496076 |
Recruitment Status :
Completed
First Posted : August 3, 2020
Last Update Posted : August 16, 2021
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Condition or disease |
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Sars-CoV2 Severe Neurologic Injury Ischemic Stroke Hemorrhagic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage Traumatic Brain Injury Status Epilepticus |
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 |
Actual Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Severe Neurologic Injury Outcomes During COVID-19 Crisis |
Actual Study Start Date : | April 2, 2020 |
Actual Primary Completion Date : | March 31, 2021 |
Actual Study Completion Date : | May 31, 2021 |

- In-hospital Mortality [ Time Frame: At hospital discharge, approximately 1 month ]
- 30-day mortality [ Time Frame: 30 days post-hospital discharge ]
- Limitations of patient care- Frequency of care not being provided [ Time Frame: During In-hospital course, up to 1 month ]Care treatment such as ventilator use, intubation, and/or tracheostomy
- Limitations of patient care- Conversion of DNR/DNI/CMO status [ Time Frame: During In-hospital course, up to 1 month ]

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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:
- 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

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): NCT04496076
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | Sherry H Chou, MD, MSc | University of Pittsburgh |
Responsible Party: | Sherry Hsiang-Yi Chou, Associate Professor, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT04496076 |
Other Study ID Numbers: |
STUDY20030201 |
First Posted: | August 3, 2020 Key Record Dates |
Last Update Posted: | August 16, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Brain Injuries Ischemic Stroke Brain Injuries, Traumatic Subarachnoid Hemorrhage Cerebral Hemorrhage Status Epilepticus Hemorrhagic Stroke Hemorrhage Wounds and Injuries Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Pathologic Processes Intracranial Hemorrhages Seizures Neurologic Manifestations |