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

N/AActive Not RecruitingNCT00178659

The University of Texas Health Science Center, Houston260 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

Brain Injuries, Traumatic Traumatic Brain Injury

Interventions

Blood/saliva samples for protein/molecular analysisOTHER

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

Sex: ALLMin age: 14 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas, Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Elevated intracranial pressure

Intracranial pressure \>20mmHg

Time frame: within the first 10 days post injury

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.