Dysregulated CNS Inflammation After Acute Brain Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 101 |
| Updated: | 3/17/2019 |
| Start Date: | January 2, 2018 |
| End Date: | July 30, 2019 |
| Contact: | Linda J Van Eldik, PhD |
| Email: | linda.vaneldik@uky.edu |
| Phone: | 859-257-5566 |
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.
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.
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).
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).
Inclusion Criteria:
- severe, non-penetrating TBI or aSAH
- must have a ventriculostomy (EVD) placed by the UK Neurosurgery service within 12
hours of primary traumatic episode
Exclusion Criteria:
- 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
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