Characterization of Human Autoantibody Titers After Central Nervous System Insult (CHAT CNS)

April 11, 2023 updated by: University of Utah
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitate Autoantibodies
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autoantibody Correlation
Time Frame: 5 years
Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
5 years
Autoantibody Production and History
Time Frame: 5 years
Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Gregory WJ Hawryluk, MD, Ph.D., University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 20, 2019

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHAT-00081214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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