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

NCT ID: NCT00178659

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2030-12-31

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.

Conditions

Brain Injuries, Traumatic; Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 healthy volunteers

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

Blood/saliva samples for protein/molecular analysis

Intervention Type: OTHER

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)

2 head trauma

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

Blood/saliva samples for protein/molecular analysis

Intervention Type: OTHER

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)

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

Blood/saliva samples for protein/molecular analysis

Intervention Type: OTHER

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)

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

Blood/saliva samples for protein/molecular analysis

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

blood samples; saliva samples

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TIRR/Mission Connect

OTHER

Sponsor Role: collaborator

The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Georgene Hergenroeder

Associate Professor, Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pramod Dash, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas, Houston

Locations

The University of Texas, Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20883153 (View on PubMed)

Hergenroeder 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.

Reference Type: BACKGROUND

PMID: 20222971 (View on PubMed)

Hergenroeder 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.

Reference Type: BACKGROUND

PMID: 18260791 (View on PubMed)

Other Identifiers

N-13-04-040

Identifier Type: -

Identifier Source: secondary_id

HSC-MS-04-040

Identifier Type: -

Identifier Source: org_study_id