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NCT04496076 Clinical Trial

COVID-19 Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:
Severe Neurologic Injury Outcomes During COVID-19 Crisis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04496076
Other study ID # STUDY20030201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2, 2020
Est. completion date May 31, 2021

Study information
Verified date April 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date May 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital Mortality At hospital discharge, approximately 1 month
Primary 30-day mortality 30 days post-hospital discharge
Secondary 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
Secondary Limitations of patient care- Conversion of DNR/DNI/CMO status During In-hospital course, up to 1 month
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