Dysregulated CNS Inflammation After Acute Brain Injury

August 28, 2019 updated by: Linda Van Eldik, University of Kentucky
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.

Study Overview

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

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
        • University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 101 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants selected will come from those who have been admitted to the University of Kentucky (UK) medical center

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
CSF collection
For 24 months from start of the study

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Linda J Van Eldik, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2018

Primary Completion (ACTUAL)

May 24, 2019

Study Completion (ACTUAL)

May 24, 2019

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (ACTUAL)

September 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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