Hemodynamic ABI Monitor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Chicago
About this trial
The goal of this observational study is to explore the relationship of heart function with the course and outcomes after traumatic brain injuries and nontraumatic intracerebral hemorrhage. The goal is to explore association between routinely collected hemodynamic and brain monitoring data.
Participants already taking intervention A as part of their regular medical care and the investigators will follow up with participants 6 months after discharging the hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to the University of Chicago Medical Center Neurocritical Care Unit
Adults between 18 years and 80
Admitted with Traumatic brain injury blunt and penetrating or nontraumatic intracerebral hemorrhage
post-resuscitation Glasgow Coma Scale (GCS) <9
Disqualifiers
None
Trial population
Admitted to the University of Chicago Medical Center Neurocritical Care Unit
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
functional outcomes
Primary endpoints are functional outcomes and quality of life at 180 days after hospital discharge. The follow-up functional status and quality of life measures will be done by telephone, in-person at their regularly scheduled follow-up appointment, or by email, for less than 30 minutes using validated instruments and/or using a web-based REDCap survey. However, these surveys can also be completed during the subject's 180-day follow up visit with their doctor or a telephone follow-up. The follow up telephone call/visit will last for less than 30 minutes and will consist of a series of validated instruments/questionnaires. The following instruments will be used: Glasgow Outcome Scale Extended (GOSE) to ascertain functional status The GOSE score ranges from 1 to 8, with the minimum score of 1 indicating Death and the highest score of 8 representing a Good Recovery, signifying a good outcome and a return to pre-injury functioning.
Time frame
180 days after discharging the hospitalSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
Baxter Healthcare Corporation
Collaborator
Source ClinicalTrials.gov