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Recovery Trajectory for Coma and Disorders of Consciousness

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study aims to better understand recovery after coma caused by serious neurologic illness or injury. Patients who are unconscious (in a coma or disorder of consciousness) due to conditions such as stroke, cardiac arrest, traumatic brain injury, seizures, brain infection, or other neurologic emergencies may be enrolled during their hospitalization. The purpose of this observational research study is to learn which medical, neurologic, psychological, and social factors are associated with recovery over time. Researchers will collect information from the medical record during hospitalization, including details about the patient's illness, treatments received, brain imaging, and neurologic examinations. For patients who survive hospitalization, the study team will contact participants or their caregivers after discharge to assess recovery at scheduled time points using questionnaires and structured interviews about physical function, quality of life, emotional well-being, and daily activities. This study does not assign participants to any experimental treatment. Participation will not change the medical care patients receive. Information learned from this study may help improve future care for patients with coma and disorders of consciousness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than or equal to 18 years on the day of hospital admission

• Coma duration of at least 24 hours from presentation to the receiving hospital, or died prior to the 24 hour timepoint without return of consciousness. Coma defined as: GCS score of less than or equal to 10 AND GCS score of less than 6 on the motor component of the GCS(not following commands) AND GCS score less than 3 on the verbal component AND alteration of consciousness not explained by sedation only

• Coma due to a neurological process (Including but not limited to: trauma, stroke, hypoxic- ischemic brain injury (HIBI), CNS infection, seizure, other processes at the discretion of the investigator)

• Admission to the intensive care unit, or deceased prior to admission.

Locations
United States
California
Zuckerberg San Francisco General Hospital and Trauma Center
RECRUITING
San Francisco
Contact Information
Primary
Claude Hemphill, MD, MAS
claude.hemphill@ucsf.edu
415-476-5100
Time Frame
Start Date: 2023-09-26
Estimated Completion Date: 2033-09
Participants
Target number of participants: 2000
Treatments
Adults with Disorders of Consciousness from Acute Neurologic Injury
Adults hospitalized with coma or disorders of consciousness due to acute neurologic injury or illness, including conditions such as ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, cardiac arrest with hypoxic-ischemic brain injury, status epilepticus, central nervous system infection, toxic-metabolic encephalopathy, and other acute neurologic etiologies. Participants are enrolled during hospitalization and followed longitudinally after discharge to assess functional recovery, quality of life, emotional well-being, and other patient-centered outcomes. No intervention is assigned as part of study participation.
Sponsors
Leads: University of California, San Francisco
Collaborators: Zuckerberg San Francisco General Hospital and Trauma Center

This content was sourced from clinicaltrials.gov