Dysregulated CNS Inflammation After Acute Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Aneurysmal Subarachnoid Hemorrhage Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–101 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Lexington, Kentucky, 40536-0298, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Severe TBI - Measure of temporal profile of inflammatory proteins in CSF

Time frame: For 24 months from start of the study

CSF collection

Secondary outcomes

aSAH - Measure of temporal profile of inflammatory proteins in CSF

Time frame: For 24 months from start of the study

CSF collection

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Sep 19, 2017
Registry last updated: Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed