NCT06725108 · University of Chicago
Hemodynamic ABI Monitor
What this study is about
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.
View original scientific description
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.
Primary outcome measures
functional outcomes
Time frame: 180 days after discharging the hospital
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients who are:
- 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
Exclusion criteria
- Patients who were:
- Pre-existing heart failure
- Moribund or neurological exam suggesting imminent brain death (bilateral, fixed and dilated pupils) on admission
- Major polytrauma or admitted to the surgical trauma critical care service
Where
- Chicago, Illinois
Collaborators
Baxter Healthcare Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations