Brain Injuries, TraumaticCHAT CNSNCT03089749
Characterization of Human Autoantibody Titers After Central Nervous System Insult
An observational study of Brain Injuries, Traumatic and Spinal Cord Trauma, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic, Spinal Cord Trauma, Intracranial Neoplasm
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 20 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population includes patients admitted to the University of Utah and its covered entities.
Who may be able to join
- Have a severe traumatic brain injury
- Have spinal cord injury ASIA grade A, B or C
- Undergoing resection of intra-axial brain tumors
Who cannot join
- Participant who is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
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.
Read the detailed description
Study Objectives:
We aim to:
- 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.
- Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
- Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.
- Medical subject headings
- Brain Injuries, Traumatic, Spinal Cord Injuries, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Autoantibody Correlation
Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
Measured: 5 years
Autoantibody Production and History
Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startMay 2015
- Primary completion20 May 2019
- Study completion20 May 2019
Why it stopped: This study has been administratively closed by the IRB as of 5/20/2019. This administrative closure was required because of the study expiration on 4/29/2019 and a continuing review application for re-approval of the study was not submitted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory WJ Hawryluk, MD, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089749
- Sponsor's protocol ID
- CHAT-00081214
- Acronym
- CHAT CNS
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2017
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24507518Becker 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.
PubMed 15931160Becker 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.
PubMed 21799171Giunta 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.
PubMed 22849382Noble 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.
PubMed 2706482Hayes 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.
PubMed 12165135
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Human Autoantibody Titers After Central Nervous System Insult
- ClinicalTrials.gov ID
- NCT03089749
- Acronym / sponsor ID
- CHAT CNS / CHAT-00081214
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study has been administratively closed by the IRB as of 5/20/2019. This administrative closure was required because of the study expiration on 4/29/2019 and a continuing review application for re-approval of the study was not submitted.
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
- Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes patients admitted to the University of Utah and its covered entities.
Key inclusion criteria (3 listed)
- Have a severe traumatic brain injury
- Have spinal cord injury ASIA grade A, B or C
- Undergoing resection of intra-axial brain tumors
Key exclusion criteria (1 listed)
- Participant who is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Autoantibody Correlation
Time frame: 5 years
Autoantibody Production and History
Time frame: 5 years
Results and safety
The study was stopped early (reason given: This study has been administratively closed by the IRB as of 5/20/2019. This administrative closure was required because of the study expiration on 4/29/2019 and a continuing review application for re-approval of the study was not submitted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 24507518Robinson 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.
- Background: PubMed 15931160Becker 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.
- Background: PubMed 21799171Becker 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.
- Background: PubMed 22849382Giunta 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.
- Background: PubMed 2706482Noble 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.
- Background: PubMed 12165135Hayes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory WJ Hawryluk, MD, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic and Spinal Cord Trauma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study has been administratively closed by the IRB as of 5/20/2019. This administrative closure was required because of the study expiration on 4/29/2019 and a continuing review application for re-approval of the study was not submitted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitate Autoantibodies (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089749, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.