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

NCT00178659 | Active Not Recruiting

• 2 other identifiers: HSC-MS-04-040N-13-04-040
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Injuries, Traumatic; Traumatic Brain Injury

Keywords

Traumatic Brain Injury; TBI (Traumatic Brain Injury); Proteomics

Outcome Measures

Primary Outcomes (1)

• Elevated intracranial pressure

  Intracranial pressure \>20mmHg

  within the first 10 days post injury

Study Arms (4)

1 healthy volunteers

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

Other: Blood/saliva samples for protein/molecular analysis

2 head trauma

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

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

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

Other: Blood/saliva samples for protein/molecular analysis

Interventions

Blood/saliva samples for protein/molecular analysis 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)

Also known as: blood samples, saliva samples

1 healthy volunteers; 2 head trauma; 3 orthopedic injury; 4 Mild TBI

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.

You may qualify if:

• 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
• 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

You may not qualify if:

• Inability to obtain informed consent

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• TIRR/Mission Connect: collaborator
• The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston: collaborator

Study Sites (1)

The University of Texas, Houston

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 20883153 BACKGROUND

• 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.

  PMID: 20222971 BACKGROUND

• 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.

  PMID: 18260791 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples for use in identifying proteins related to head trauma

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pramod Dash, PhD

  The University of Texas, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2004
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)