An observational study in Brain Injuries, Traumatic and Traumatic Brain Injury, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 14 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by The University of Texas Health Science Center, Houston · Observational
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's enrollment of 260 is above the median of 118 across 562 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.
The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:
or The mild TBI patients will be defined as those experiencing,
Non-penetrating head trauma manifesting one or more of the following:
Exclusion Criteria:
Healthy volunteers to act as controls - Recruitment is complete for this cohort
Other: Blood/saliva samples for protein/molecular analysis
Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort
Other: Blood/saliva samples for protein/molecular analysis
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 Recruitment is complete.
Other: Blood/saliva samples for protein/molecular analysis
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 Recruitment is complete.
Other: Blood/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)
Also known as: blood samples, saliva samples
Elevated intracranial pressure
Intracranial pressure \>20mmHg
Time frame: within the first 10 days post injury
Plan to share: No — There is no plan to make individual participant data available
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston