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Characterization of Human Autoantibody Titers After Central Nervous System Insult

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03089749
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Utah
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gregory WJ Hawryluk, MD, Ph.D.
Principal Investigator Affiliation	University of Utah
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Terminated
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Injuries, Traumatic, Spinal Cord Trauma, Intracranial Neoplasm

Additional Details

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.

Arms & Interventions

Arms

: Control

Participants with no history of Traumatic Brain Injury, Traumatic Spinal Cord Injury or Intracranial Neoplasm. A single draw of 5 mL of blood will be obtained as well as demographic information and a brief medical history to act as comparison data to the other groups.

: Traumatic Brain Injury (TBI)

Patients with Acute Severe TBI (post-resuscitation GCS of 8 or less). Participants will have blood draws at the time points identified below: - At 24h from the time of CNS insult - At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult - At 3, 6, and 12 months from the time of CNS insult - Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained from the participant. Demographic data will be collected, including: - Age - Sex - History of prior CNS insult - Clinical indicators of severity including baseline, post-resuscitation Glasgow Coma Scale (GCS) scores for brain injury patients - Radiographic indicators of severity including volume of intracranial hemorrhage, effacement of basal cisterns, amount of midline shift as well as Marshall and Rotterdam CT head scores for TBI. - Outcome data including discharge, 3-, 6-, and 12-month extended Glasgow Outcome Scale (GOS) scores

: Spinal Cord Injury (SCI)

Patients with acute spinal cord injury (SCI) (post-resuscitation ASIA score of C, B or A). Participants will have blood draws at the time points identified below: - At 24h from the time of CNS insult - At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult - At 3, 6, and 12 months from the time of CNS insult - Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained. Demographic data will be collected, including: - Age - Sex - History of prior CNS insult - Clinical indicators of severity including baseline post-resuscitation American Spinal Injury Association (ASIA) score and ASIA impairment scale (AIS) grade for patients with spinal cord injury (SCI) - Radiographic indicators of severity including the degree of cord compression, area of cord signal change and the SFGH MRI scale will be employed. - Outcome data including discharge, 3-, 6-, and 12-month ASIA scores for SCI patients

: Intracranial Neoplasm

Patients undergoing resection of intra-axial brain tumors (commonly gliomas such as glioblastoma multiforme, astrocytomas and oligodendrogliomas). All participants will have blood draws at the time points identified below: - At 24h from the time of CNS insult - At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult - At 3, 6, and 12 months from the time of CNS insult - Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained. Demographic data will be collected, including: - Age - Sex - History of prior CNS insult - Clinical indicators of severity including baseline, Karnofsky and Modified Rankin performance status scores for oncology patients. - Radiographic indicators of severity including the pre- and postoperative tumor volumes that will be quantitated. - Outcome data including discharge, 3-, 6-, and 12-month Karnofsky and Modified Rankin scores for oncology patients.

Interventions

Contact a Trial Team

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University of Utah Hospital, Salt Lake City, Utah

Status

Address

University of Utah Hospital

Salt Lake City, Utah, 84132

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