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

This study is currently recruiting participants.
Verified May 2013 by The University of Texas Health Science Center, Houston
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 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Brain Injuries, Traumatic
Traumatic Brain Injury
 Other: Blood/saliva samples for protein/molecular analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Biospecimen Retention:   Samples Without DNA

Plasma and serum samples for use in identifying proteins related to head trauma


Estimated Enrollment: 260
Study Start Date: July 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 healthy volunteers
Healthy volunteers to act as controls
 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
2 head trauma
Head trauma patients meeting enrollment criteria
 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
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
 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
4 Mild TBI

The mild TBI patients will be defined as those admitted to the ED 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
 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

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

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178659

Contacts
Contact: Georgene W Hergenroeder, BSN MHA, RN Georgene.W.Hergenroeder@uth.tmc.edu

Locations
United States, Texas
The University of Texas, Houston Recruiting
Houston, Texas, United States, 77030
Contact: Georgene W Hergenroeder, MHA RN         Georgene.W.Hergenroeder@uth.tmc.edu    
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
Principal Investigator: Georgene Hergenroeder, MHA RN The University of Texas, Houston
Study Chair: Guy Clifton, MD The University of Texas, Houston
  More Information

No publications provided

Responsible Party: Georgene Hergenroeder, Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178659     History of Changes
Other Study ID Numbers: HSC-MS-04-040, N-13-04-040, M01-RR 02558
Study First Received: September 12, 2005
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Traumatic Brain Injury
TBI (Traumatic Brain Injury)
Proteomics

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013