Brain Injuries, TraumaticProteomicsNCT00178659
Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
An observational study of Brain Injuries, Traumatic and Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic, Traumatic Brain Injury
- What is being tested?
- Blood/saliva samples for protein/molecular analysis
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2004to 8 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.
Who may be able to join
- 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:
- Fracture confirmed radiographically
Show all 21Show fewer
- No head trauma
- No other known inflammatory process or infection
- No history of neurological or psychiatric disorders or alcohol or drug dependency.
- or The mild TBI patients will be defined as those experiencing,
- 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
Who cannot join
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas, Houston
Houston, Texas, 77030
About this study
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).
Read the 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.
- Conditions
- Brain Injuries, Traumatic, Traumatic Brain Injury
- Being tested
- Blood/saliva samples for protein/molecular analysis
- Keywords
- Traumatic Brain Injury, TBI (Traumatic Brain Injury), Proteomics
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood/saliva samples for protein/molecular analysisOther
Also called blood samples, saliva 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)
| Study group | Role | What they receive |
|---|---|---|
| 1 healthy volunteers | Healthy volunteers to act as controls - Recruitment is complete for this cohort Receives: Other: Blood/saliva samples for protein/molecular analysis | |
| 2 head trauma | Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort Receives: Other: Blood/saliva samples for protein/molecular analysis | |
| 3 orthopedic injury | 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. Receives: Other: Blood/saliva samples for protein/molecular analysis | |
| 4 Mild TBI | 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. Receives: Other: Blood/saliva samples for protein/molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated intracranial pressure
Intracranial pressure >20mmHg
Measured: within the first 10 days post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start25 Aug 2004
- Primary completion30 Oct 2015
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR/Mission Connect, The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
- Responsible party
- Principal investigator, Georgene Hergenroeder, The University of Texas Health Science Center, Houston
- Investigators
- Pramod Dash, PhD, Principal investigator, The University of Texas, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178659
- Sponsor's protocol ID
- HSC-MS-04-040
- Other IDs
- N-13-04-040
- Acronym
- Proteomics
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2005
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available
Publications
Redell JB, Moore AN, Ward NH 3rd, Hergenroeder GW, Dash PK. Human traumatic brain injury alters plasma microRNA levels. J Neurotrauma. 2010 Dec;27(12):2147-56. doi: 10.1089/neu.2010.1481. Epub 2010 Nov 23.
PubMed 20883153Hergenroeder GW, Moore AN, McCoy JP Jr, Samsel L, Ward NH 3rd, Clifton GL, Dash PK. Serum IL-6: a candidate biomarker for intracranial pressure elevation following isolated traumatic brain injury. J Neuroinflammation. 2010 Mar 11;7:19. doi: 10.1186/1742-2094-7-19.
PubMed 20222971Hergenroeder G, Redell JB, Moore AN, Dubinsky WP, Funk RT, Crommett J, Clifton GL, Levine R, Valadka A, Dash PK. Identification of serum biomarkers in brain-injured adults: potential for predicting elevated intracranial pressure. J Neurotrauma. 2008 Feb;25(2):79-93. doi: 10.1089/neu.2007.0386.
PubMed 18260791
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
- ClinicalTrials.gov ID
- NCT00178659
- Acronym / sponsor ID
- Proteomics / HSC-MS-04-040
- Conditions
- Brain Injuries, Traumatic, Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, TBI (Traumatic Brain Injury), Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- TIRR/Mission Connect, The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
- Study start
- 25 Aug 2004 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 healthy volunteers | – | Other: Blood/saliva samples for protein/molecular analysisHealthy volunteers to act as controls - Recruitment is complete for this cohort |
| 2 head trauma | – | Other: Blood/saliva samples for protein/molecular analysisHead trauma patients meeting enrollment criteria - Recruitment is complete for this cohort |
| 3 orthopedic injury | – | Other: Blood/saliva samples for protein/molecular analysisThe 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. |
| 4 Mild TBI | – | Other: Blood/saliva samples for protein/molecular analysisThe 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.
Key inclusion criteria (21 listed)
- 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:
Key exclusion criteria (1 listed)
- Inability to obtain informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood/saliva samples for protein/molecular analysisAlso: blood samples, saliva samplesBloods 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) | Other | 1 healthy volunteers, 2 head trauma, 3 orthopedic injury, 4 Mild TBI |
Primary outcome
Elevated intracranial pressure
Time frame: within the first 10 days post injury
Intracranial pressure >20mmHg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 20883153Redell JB, Moore AN, Ward NH 3rd, Hergenroeder GW, Dash PK. Human traumatic brain injury alters plasma microRNA levels. J Neurotrauma. 2010 Dec;27(12):2147-56. doi: 10.1089/neu.2010.1481. Epub 2010 Nov 23.
- Background: PubMed 20222971Hergenroeder GW, Moore AN, McCoy JP Jr, Samsel L, Ward NH 3rd, Clifton GL, Dash PK. Serum IL-6: a candidate biomarker for intracranial pressure elevation following isolated traumatic brain injury. J Neuroinflammation. 2010 Mar 11;7:19. doi: 10.1186/1742-2094-7-19.
- Background: PubMed 18260791Hergenroeder G, Redell JB, Moore AN, Dubinsky WP, Funk RT, Crommett J, Clifton GL, Levine R, Valadka A, Dash PK. Identification of serum biomarkers in brain-injured adults: potential for predicting elevated intracranial pressure. J Neurotrauma. 2008 Feb;25(2):79-93. doi: 10.1089/neu.2007.0386.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pramod Dash, PhD principal investigator
The University of Texas, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic and Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elevated intracranial pressure (time frame: within the first 10 days post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.