- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03287557
Dysregulated CNS Inflammation After Acute Brain Injury
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536-0298
- University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe TBI - Measure of temporal profile of inflammatory proteins in CSF
Time Frame: For 24 months from start of the study
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CSF collection
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For 24 months from start of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aSAH - Measure of temporal profile of inflammatory proteins in CSF
Time Frame: For 24 months from start of the study
|
CSF collection
|
For 24 months from start of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Linda J Van Eldik, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Inflammation
- Brain Injuries
- Wounds and Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Subarachnoid Hemorrhage
Other Study ID Numbers
- 17-0583-F6A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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