COVID-19 Brain Injury

NCT04496076 | Completed

• 1 other identifier: STUDY20030201
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• In-hospital Mortality

  At hospital discharge, approximately 1 month

• 30-day mortality

  30 days post-hospital discharge

Secondary Outcomes (2)

• Limitations of patient care- Frequency of care not being provided

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Brain Injuries, Traumatic; Status Epilepticus

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Seizures; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sherry H Chou, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: August 3, 2020
• Study Start: April 2, 2020
• Primary Completion: March 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)