Traumatic Brain InjuryNCT03287557
Dysregulated CNS Inflammation After Acute Brain Injury
An observational study of Traumatic Brain Injury and Aneurysmal Subarachnoid Hemorrhage, run by University of Kentucky at 1 site in United States.
Trial summary
By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period. Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Traumatic Brain Injury, Aneurysmal Subarachnoid Hemorrhage
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 24 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 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants selected will come from those who have been admitted to the University of Kentucky (UK) medical center
Who may be able to join
- severe, non-penetrating TBI or aSAH
- must have a ventriculostomy (EVD) placed by the UK Neurosurgery service within 12 hours of primary traumatic episode
Who cannot join
- non-survivable brain injury or other organ system injury
- life expectancy is five days or less
- penetrating TBI
- status epilepticus upon arrival to the hospital
- severe ischemic heart disease or congestive heart failure, myocardial infarction, or spinal cord injury
- Takotsubo cardiomyopathy secondary to the SAH
- active cancer or have been treated for cancer within the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
Lexington, Kentucky, 40536-0298
About this study
By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.
Read the detailed description
This pilot project is a prospective, observational study in 20 patients who are admitted to University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe, non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).
All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who are admitted to the neuroscience or trauma intensive care units will be screened for potential inclusion into this study. Once a potential participant is identified, the legally-authorized representative will be approached for study consent and HIPAA authorization. If the participant regains consent capacity before the end of the cerebrospinal fluid (CSF) collection period, assent will be obtained from the research participant.
In this research study, up to 5 small samples of CSF, will be carefully removed from the device, already in place, that drains excess CSF from the participant's head. The samples will be less than 1 teaspoon (< 5 mL) each. These samples will be frozen and stored until samples from approximately 20 participants have been obtained.
These samples will then be prepared and sent to a research laboratory to analyze the proteins in the samples collected from each research participant.
Because the results of this study will not affect the treatment participants receive in or outside of the hospital, the investigator will not share the results of this study with the participant, their doctor or their family member(s).
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe TBI - Measure of temporal profile of inflammatory proteins in CSF
CSF collection
Measured: For 24 months from start of the study
Secondary outcomes (1)
aSAH - Measure of temporal profile of inflammatory proteins in CSF
CSF collection
Measured: For 24 months from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start2 Jan 2018
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Van Eldik, University of Kentucky
- Investigators
- Linda J Van Eldik, PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287557
- Sponsor's protocol ID
- 17-0583-F6A
- Status last verified
- Aug 2019
- First submitted
- 12 Sep 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulated CNS Inflammation After Acute Brain Injury
- ClinicalTrials.gov ID
- NCT03287557
- Acronym / sponsor ID
- 17-0583-F6A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 19 Sep 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.
By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.
Detailed description
This pilot project is a prospective, observational study in 20 patients who are admitted to University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe, non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).
All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who are admitted to the neuroscience or trauma intensive care units will be screened for potential inclusion into this study. Once a potential participant is identified, the legally-authorized representative will be approached for study consent and HIPAA authorization. If the participant regains consent capacity before the end of the cerebrospinal fluid (CSF) collection period, assent will be obtained from the research participant.
In this research study, up to 5 small samples of CSF, will be carefully removed from the device, already in place, that drains excess CSF from the participant's head. The samples will be less than 1 teaspoon (< 5 mL) each. These samples will be frozen and stored until samples from approximately 20 participants have been obtained.
These samples will then be prepared and sent to a research laboratory to analyze the proteins in the samples collected from each research participant.
Because the results of this study will not affect the treatment participants receive in or outside of the hospital, the investigator will not share the results of this study with the participant, their doctor or their family member(s).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants selected will come from those who have been admitted to the University of Kentucky (UK) medical center
Key inclusion criteria (2 listed)
- severe, non-penetrating TBI or aSAH
- must have a ventriculostomy (EVD) placed by the UK Neurosurgery service within 12 hours of primary traumatic episode
Key exclusion criteria (7 listed)
- non-survivable brain injury or other organ system injury
- life expectancy is five days or less
- penetrating TBI
- status epilepticus upon arrival to the hospital
- severe ischemic heart disease or congestive heart failure, myocardial infarction, or spinal cord injury
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
Severe TBI - Measure of temporal profile of inflammatory proteins in CSF
Time frame: For 24 months from start of the study
CSF collection
1 secondary outcome
aSAH - Measure of temporal profile of inflammatory proteins in CSF
Time frame: For 24 months from start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Linda J Van Eldik, PhD study director
University of Kentucky
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 Traumatic Brain Injury and Aneurysmal Subarachnoid Hemorrhage, run by University of Kentucky 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 29 Aug 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severe TBI - Measure of temporal profile of inflammatory proteins in CSF (time frame: For 24 months from start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2019.