Hemodynamic ABI Monitor

NCT06725108 | Recruiting

• 1 other identifier: IRB23-0973
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracerebral Hemorrhage; Traumatic Brain Injury (TBI)

Keywords

Hemodynamic; Acute brain injury; Monitoring

Outcome Measures

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.

  180 days after discharging the hospital

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Admitted to the University of Chicago Medical Center Neurocritical Care Unit

You may qualify if:

• 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

You may not qualify if:

• 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
• Prisoner

Sponsors & Collaborators

• University of Chicago: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage; Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Christos Lazaridis, MD

  university of Chicago attending

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farima Fakhri, MD

CONTACT

3126102482; farima.fakhri@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): December 6, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)