Overview

This trial is active, not recruiting.

Conditions brain injuries, traumatic, traumatic brain injury
Treatment blood/saliva samples for protein/molecular analysis
Sponsor The University of Texas Health Science Center, Houston
Collaborator TIRR/Mission Connect
Start date July 2004
End date April 2017
Trial size 260 participants
Trial identifier NCT00178659, HSC-MS-04-040, M01RR002558, N-13-04-040

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Healthy volunteers to act as controls - Recruitment is complete for this cohort
blood/saliva samples for protein/molecular analysis blood samples
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)
Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort
blood/saliva samples for protein/molecular analysis blood samples
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)
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
blood/saliva samples for protein/molecular analysis blood samples
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)
The mild TBI patients will be defined as those admitted to the ED experiencing, - Recruitment is complete for this cohort Non-penetrating head trauma manifesting one or more of the following: Loss of consciousness Post-traumatic amnesia Altered mental status Focal neurologic deficits, seizure GCS> 12 No abnormalities on CT other than contusion No operative Lesions Length of hospital stay < 48 hrs No other known inflammatory process or infection No history of neurological or psychiatric disorders or alcohol or drug dependency
blood/saliva samples for protein/molecular analysis blood samples
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)

Eligibility Criteria

Male or female participants from 14 years up to 65 years old.

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

Additional Information

Official title Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
Principal investigator Pramod Dash, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston.