Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00178659
Acronym
Proteomics
Enrollment
260
Registered
2005-09-15
Start date
2004-08-25
Completion date
2026-06-08
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic, Traumatic Brain Injury

Keywords

Traumatic Brain Injury, TBI (Traumatic Brain Injury), Proteomics

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.

Interventions

OTHERBlood/saliva samples for protein/molecular analysis

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)

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER
TIRR/Mission Connect
CollaboratorOTHER
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Elevated intracranial pressurewithin the first 10 days post injuryIntracranial pressure \>20mmHg

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPramod Dash, PhD

The University of Texas, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026