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

Traumatic Brain Injury Clinical Trial

— Proteomics  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00178659
• Other study ID #: HSC-MS-04-040
• Secondary ID: N-13-04-040
• Status: Active, not recruiting
• Start date: July 2004
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Intracranial Hypertension
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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)

Locations

Country	Name	City	State
United States	The University of Texas, Houston	Houston	Texas

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevated intracranial pressure	Intracranial pressure >20mmHg	within the first 10 days post injury