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Active Not RecruitingNCT00178659

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
260 (actual)
Sponsor
The University of Texas Health Science Center, Houston · Academic / Other
Sex
All
Age
14 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBlood/saliva samples for protein/molecular analysisBloods 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)

Timeline

Start date
2004-07-01
Primary completion
2030-12-01
Completion
2030-12-01
First posted
2005-09-15
Last updated
2025-08-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00178659. Inclusion in this directory is not an endorsement.