Characterization of Human Autoantibody Titers After Central Nervous System Insult

NCT03089749 | Terminated

• 1 other identifier: CHAT-00081214
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic; Spinal Cord Trauma; Intracranial Neoplasm

Outcome Measures

Primary Outcomes (1)

• Quantitate Autoantibodies

  Quantitate CNS autoantibody development and temporal course in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries.

  5 years

Secondary Outcomes (2)

• Autoantibody Correlation

  5 years

• Autoantibody Production and History

  5 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes patients admitted to the University of Utah and its covered entities.

You may qualify if:

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

You may not qualify if:

• Participant who is pregnant

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (6)

• Robinson AP, Harp CT, Noronha A, Miller SD. The experimental autoimmune encephalomyelitis (EAE) model of MS: utility for understanding disease pathophysiology and treatment. Handb Clin Neurol. 2014;122:173-89. doi: 10.1016/B978-0-444-52001-2.00008-X.

  PMID: 24507518 BACKGROUND

• Becker KJ, Kindrick DL, Lester MP, Shea C, Ye ZC. Sensitization to brain antigens after stroke is augmented by lipopolysaccharide. J Cereb Blood Flow Metab. 2005 Dec;25(12):1634-44. doi: 10.1038/sj.jcbfm.9600160.

  PMID: 15931160 BACKGROUND

• Becker KJ, Kalil AJ, Tanzi P, Zierath DK, Savos AV, Gee JM, Hadwin J, Carter KT, Shibata D, Cain KC. Autoimmune responses to the brain after stroke are associated with worse outcome. Stroke. 2011 Oct;42(10):2763-9. doi: 10.1161/STROKEAHA.111.619593. Epub 2011 Jul 28.

  PMID: 21799171 BACKGROUND

• Giunta B, Obregon D, Velisetty R, Sanberg PR, Borlongan CV, Tan J. The immunology of traumatic brain injury: a prime target for Alzheimer's disease prevention. J Neuroinflammation. 2012 Aug 1;9:185. doi: 10.1186/1742-2094-9-185.

  PMID: 22849382 BACKGROUND

• Noble LJ, Wrathall JR. Distribution and time course of protein extravasation in the rat spinal cord after contusive injury. Brain Res. 1989 Mar 13;482(1):57-66. doi: 10.1016/0006-8993(89)90542-8.

  PMID: 2706482 BACKGROUND

• Hayes KC, Hull TC, Delaney GA, Potter PJ, Sequeira KA, Campbell K, Popovich PG. Elevated serum titers of proinflammatory cytokines and CNS autoantibodies in patients with chronic spinal cord injury. J Neurotrauma. 2002 Jun;19(6):753-61. doi: 10.1089/08977150260139129.

  PMID: 12165135 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Brain Injuries, Traumatic; Spinal Cord Injuries; Brain Neoplasms

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Gregory WJ Hawryluk, MD, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 24, 2017
• Study Start: May 1, 2015
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

US (1)