Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 healthy volunteers Healthy volunteers to act as controls - Recruitment is complete for this cohort |
Other: Blood/saliva samples for protein/molecular analysis
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)
Other Names:
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| 2 head trauma Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort |
Other: Blood/saliva samples for protein/molecular analysis
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)
Other Names:
|
| 3 orthopedic injury 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
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)
Other Names:
|
| 4 Mild TBI 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
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)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Elevated intracranial pressure [within the first 10 days post injury]
Intracranial pressure >20mmHg
Eligibility Criteria
Criteria
Inclusion Criteria:
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14-65 years old
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Non-penetrating brain injury
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ICP monitor or
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas, Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- TIRR/Mission Connect
- The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Investigators
- Principal Investigator: Pramod Dash, PhD, The University of Texas, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
- Hergenroeder G, Redell JB, Moore AN, Dubinsky WP, Funk RT, Crommett J, Clifton GL, Levine R, Valadka A, Dash PK. Identification of serum biomarkers in brain-injured adults: potential for predicting elevated intracranial pressure. J Neurotrauma. 2008 Feb;25(2):79-93. doi: 10.1089/neu.2007.0386.
- Hergenroeder GW, Moore AN, McCoy JP Jr, Samsel L, Ward NH 3rd, Clifton GL, Dash PK. Serum IL-6: a candidate biomarker for intracranial pressure elevation following isolated traumatic brain injury. J Neuroinflammation. 2010 Mar 11;7:19. doi: 10.1186/1742-2094-7-19.
- Redell JB, Moore AN, Ward NH 3rd, Hergenroeder GW, Dash PK. Human traumatic brain injury alters plasma microRNA levels. J Neurotrauma. 2010 Dec;27(12):2147-56. doi: 10.1089/neu.2010.1481. Epub 2010 Nov 23.
- HSC-MS-04-040
- N-13-04-040