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

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Traumatic Brain Injury; Brain Injuries, Traumatic

Treatments: Other: Blood/saliva samples for protein/molecular analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00178659

HSC-MS-04-040

N-13-04-040

Details and patient eligibility

About

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).

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

260 participants in 4 patient groups

1 healthy volunteers

Description:

Healthy volunteers to act as controls - Recruitment is complete for this cohort

Treatment:

Other: Blood/saliva samples for protein/molecular analysis

2 head trauma

Description:

Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort

Treatment:

Other: Blood/saliva samples for protein/molecular analysis

3 orthopedic injury

Description:

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

Treatment:

Other: Blood/saliva samples for protein/molecular analysis

4 Mild TBI

Description:

The mild TBI patients will be defined as those admitted to the ED experiencing, - Recruitment is complete for this cohort 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

Treatment:

Other: Blood/saliva samples for protein/molecular analysis