Traumatic Brain Injury Clinical Trial
Official title:
Severe Neurologic Injury Outcomes During COVID-19 Crisis
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 |
Verified date | April 2021 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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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