Clinical trial NCT04496076: COVID-19 Brain Injury
Official title: Severe Neurologic Injury Outcomes During COVID-19 Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Severe Neurologic Injury
Ischemic Stroke
Hemorrhagic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Traumatic Brain Injury
Status Epilepticus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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).

Eligibility 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

Primary outcomes:
measure: In-hospital Mortality
timeFrame: At hospital discharge, approximately 1 month
measure: 30-day mortality
timeFrame: 30 days post-hospital discharge
Secondary outcomes:
measure: Limitations of patient care- Frequency of care not being provided
timeFrame: During In-hospital course, up to 1 month
measure: Limitations of patient care- Conversion of DNR/DNI/CMO status
timeFrame: During In-hospital course, up to 1 month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sherry H Chou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: