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

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ClinicalTrials.gov Identifier: NCT03089749
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Hawryluk, University of Utah

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.

Condition or disease
Brain Injuries, Traumatic Spinal Cord Trauma Intracranial Neoplasm

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Human Autoantibody Titers After Central Nervous System Insult
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089749


Contacts
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Contact: Gregory WJ Hawryluk, MD, Ph.D. 801-581-6908 gregory.hawryluk@hsc.utah.edu

Locations
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United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Gregory WJ Hawryluk, MD, Ph.D.    801-581-6908    gregory.hawryluk@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Gregory WJ Hawryluk, MD, Ph.D. University of Utah

Publications:
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Responsible Party: Gregory Hawryluk, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03089749     History of Changes
Other Study ID Numbers: CHAT-00081214
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Spinal Cord Injuries
Brain Neoplasms
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
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs