Clinical trial NCT03089749: Characterization of Human Autoantibody Titers After Central Nervous System Insult
Official title: Characterization of Human Autoantibody Titers After Central Nervous System Insult
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Injuries, Traumatic
Spinal Cord Trauma
Intracranial Neoplasm
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes patients admitted to the University of Utah and its covered entities.

Brief summary: The aim of the study is to quantitate Central Nervous System (CNS) autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries.

Detailed description: Study Objectives:

We aim to:

1. Quantitate CNS autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries. We also aim to characterize the temporal course of this response.
2. Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
3. Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Eligibility criteria: Inclusion Criteria:

* Have a severe traumatic brain injury
* Have spinal cord injury ASIA grade A, B or C
* Undergoing resection of intra-axial brain tumors

Exclusion Criteria:

* Participant who is pregnant

Primary outcomes:
measure: Quantitate Autoantibodies
timeFrame: 5 years
Secondary outcomes:
measure: Autoantibody Correlation
timeFrame: 5 years
measure: Autoantibody Production and History
timeFrame: 5 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Gregory WJ Hawryluk, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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