Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04496076
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sherry Hsiang-Yi Chou, University of Pittsburgh

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

Condition or disease
Sars-CoV2 Severe Neurologic Injury Ischemic Stroke Hemorrhagic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage Traumatic Brain Injury Status Epilepticus

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).

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. In-hospital Mortality [ Time Frame: At hospital discharge, approximately 1 month ]
  2. 30-day mortality [ Time Frame: 30 days post-hospital discharge ]

Secondary Outcome Measures :
  1. 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

  2. Limitations of patient care- Conversion of DNR/DNI/CMO status [ Time Frame: During In-hospital course, up to 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
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
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Sherry H Chou, MD, MSc University of Pittsburgh
Additional Information:
Layout table for additonal information
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: October 8, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Brain Injuries
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Status Epilepticus
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