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Clinical Trials/NCT00178659
NCT00178659
Active, not recruiting
Not Applicable

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

The University of Texas Health Science Center, Houston1 site in 1 country260 target enrollmentJuly 1, 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
260
Locations
1
Primary Endpoint
Elevated intracranial pressure
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2004
End Date
December 1, 2030
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgene Hergenroeder

Associate Professor, Neurosurgery

The University of Texas Health Science Center, Houston

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:
  • 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,

Exclusion Criteria

  • Inability to obtain informed consent

Outcomes

Primary Outcomes

Elevated intracranial pressure

Time Frame: within the first 10 days post injury

Intracranial pressure \>20mmHg

Study Sites (1)

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