Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)

Study Overview
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Brief Summary
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The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in intracranial pressure (ICP).

Detailed Description
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One of the major causes of death following brain trauma is increased intracranial pressure (ICP). Currently, there are no effective ways to predict if the ICP of a patient will reach uncontrollable levels. Various cytokines (balance between pro-and anti-inflammatory) and other factors are thought to underlie increases in ICP. The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in ICP. We propose to employ mass spectrometry, antibody array and ELISA to profile proteins in the serum of patients suffering from traumatic brain injury. These protein profiles will be compiled by a pattern recognition program that has the capacity to learn and make predictions based on the spectra and associated patient information. Each time a sample is analyzed, it is added to the database allowing the program to make increasingly accurate predictions. Protein profiles of patients with known ICP values will be analyzed. Our hypothesis is that alterations in serum protein composition will precede changes in intracranial pressure giving rise to predictable patterns that can be detected using large-scale proteomic analysis. After approximately 90 non-brain trauma and 90 brain-trauma patients are analyzed, if markers are found, the predictability of elevated ICP will be tested. If successful, this may aid the neurosurgeon in determining future courses of treatment.

Official Title
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Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)

Conditions
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Traumatic Brain Injury, Brain Injuries, Traumatic

Intervention / Treatment
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* Other: Blood/saliva samples for protein/molecular analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 14-65 years old Non-penetrating brain injury ICP monitor or Healthy volunteer or The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following: Fracture confirmed radiographically No head trauma No other known inflammatory process or infection No history of neurological or psychiatric disorders or alcohol or drug dependency. or The mild TBI patients will be defined as those experiencing, Non-penetrating head trauma manifesting one or more of the following: Loss of consciousness Post-traumatic amnesia Altered mental status Focal neurologic deficits, seizure GCS> 12 No abnormalities on CT other than contusion No operative Lesions Length of hospital stay < 48 hrs No other known inflammatory process or infection No history of neurological or psychiatric disorders or alcohol or drug dependency Exclusion Criteria: Inability to obtain informed consent

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 healthy volunteers<br>Healthy volunteers to act as controls - Recruitment is complete for this cohort | Other: Blood/saliva samples for protein/molecular analysis<br>* Bloods samples - healthy volunteers(1 time) head injury subjects (5 times). Blood and/or saliva samples mild TBI patients (2 times) and healthy volunteers (2 times)<br>* Other names: saliva samples;|
| 2 head trauma<br>Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort | Other: Blood/saliva samples for protein/molecular analysis<br>* Bloods samples - healthy volunteers(1 time) head injury subjects (5 times). Blood and/or saliva samples mild TBI patients (2 times) and healthy volunteers (2 times)<br>* Other names: saliva samples;|
| 3 orthopedic injury<br>The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following: Fracture confirmed radiographically No head trauma No other known inflammatory process or infection No history of neurological or psychiatric disorders or alcohol or drug dependency | Other: Blood/saliva samples for protein/molecular analysis<br>* Bloods samples - healthy volunteers(1 time) head injury subjects (5 times). Blood and/or saliva samples mild TBI patients (2 times) and healthy volunteers (2 times)<br>* Other names: saliva samples;|
| 4 Mild TBI<br>The mild TBI patients will be defined as those admitted to the ED experiencing, - Recruitment is complete for this cohort Non-penetrating head trauma manifesting one or more of the following: Loss of consciousness Post-traumatic amnesia Altered mental status Focal neurologic deficits, seizure GCS> 12 No abnormalities on CT other than contusion No operative Lesions Length of hospital stay < 48 hrs No other known inflammatory process or infection No history of neurological or psychiatric disorders or alcohol or drug dependency | Other: Blood/saliva samples for protein/molecular analysis<br>* Bloods samples - healthy volunteers(1 time) head injury subjects (5 times). Blood and/or saliva samples mild TBI patients (2 times) and healthy volunteers (2 times)<br>* Other names: saliva samples;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elevated intracranial pressure | Intracranial pressure >20mmHg | within the first 10 days post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, TBI (Traumatic Brain Injury), Proteomics