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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
TIRR/Mission Connect
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178659
First received: September 12, 2005
Last updated: May 10, 2016
Last verified: May 2016

September 12, 2005
May 10, 2016
July 2004
April 2017   (final data collection date for primary outcome measure)
Elevated intracranial pressure [ Time Frame: within the first 10 days post injury ] [ Designated as safety issue: No ]
Intracranial pressure >20mmHg
Not Provided
Complete list of historical versions of study NCT00178659 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (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 intracranial pressure (ICP).
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Plasma and serum samples for use in identifying proteins related to head trauma
Probability Sample
Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.
  • Brain Injuries, Traumatic
  • Traumatic Brain Injury
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:
  • blood samples
  • saliva samples
  • 1 healthy volunteers
    Healthy volunteers to act as controls - Recruitment is complete for this cohort
    Intervention: Other: Blood/saliva samples for protein/molecular analysis
  • 2 head trauma
    Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort
    Intervention: Other: Blood/saliva samples for protein/molecular analysis
  • 3 orthopedic injury

    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
    Intervention: Other: Blood/saliva samples for protein/molecular analysis
  • 4 Mild TBI

    The mild TBI patients will be defined as those admitted to the ED experiencing, - Recruitment is complete for this cohort

    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
    Intervention: Other: Blood/saliva samples for protein/molecular analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
December 2020
April 2017   (final data collection date for primary outcome measure)

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
Both
14 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178659
HSC-MS-04-040, N-13-04-040
No
No
There is no plan to make individual participant data available
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
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
Principal Investigator: Pramod Dash, PhD The University of Texas, Houston
The University of Texas Health Science Center, Houston
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP