Clinical trial NCT00178659: Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
Official title: Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Injuries, Traumatic
Traumatic Brain Injury
Keywords: Traumatic Brain Injury
TBI (Traumatic Brain Injury)
Proteomics
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: TIRR/Mission Connect
name: The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
First posted: 2005-09-15
Enrollment: 260
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.

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).

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.

Eligibility criteria: 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:

1. Fracture confirmed radiographically
2. No head trauma
3. No other known inflammatory process or infection
4. No history of neurological or psychiatric disorders or alcohol or drug dependency.

or The mild TBI patients will be defined as those experiencing,

1. Non-penetrating head trauma manifesting one or more of the following:

   * Loss of consciousness
   * Post-traumatic amnesia
   * Altered mental status
   * Focal neurologic deficits, seizure
2. GCS\> 12
3. No abnormalities on CT other than contusion
4. No operative Lesions
5. Length of hospital stay \< 48 hrs
6. No other known inflammatory process or infection
7. No history of neurological or psychiatric disorders or alcohol or drug dependency

Exclusion Criteria:

* Inability to obtain informed consent

Primary outcomes:
measure: Elevated intracranial pressure
timeFrame: within the first 10 days post injury
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas, Houston
state: Texas
Study officials:
affiliation: The University of Texas, Houston
name: Pramod Dash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.