Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 5:29 AM
Study NCT ID:
NCT00178659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and serum samples for use in identifying proteins related to head trauma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elevated intracranial pressure', 'timeFrame': 'within the first 10 days post injury', 'description': 'Intracranial pressure \\>20mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'TBI (Traumatic Brain Injury)', 'Proteomics'], 'conditions': ['Brain Injuries, Traumatic', 'Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '20883153', 'type': 'BACKGROUND', '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.'}, {'pmid': '20222971', 'type': 'BACKGROUND', '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.'}, {'pmid': '18260791', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consenting healthy volunteers, head trauma, mild head trauma or acute orthopedic injury patients meeting enrollment criteria listed below.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-65 years old\n* Non-penetrating brain injury\n* ICP monitor or\n* Healthy volunteer or\n\nThe orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:\n\n1. Fracture confirmed radiographically\n2. No head trauma\n3. No other known inflammatory process or infection\n4. No history of neurological or psychiatric disorders or alcohol or drug dependency.\n\nor The mild TBI patients will be defined as those experiencing,\n\n1. Non-penetrating head trauma manifesting one or more of the following:\n\n * Loss of consciousness\n * Post-traumatic amnesia\n * Altered mental status\n * Focal neurologic deficits, seizure\n2. GCS\\> 12\n3. No abnormalities on CT other than contusion\n4. No operative Lesions\n5. Length of hospital stay \\< 48 hrs\n6. No other known inflammatory process or infection\n7. No history of neurological or psychiatric disorders or alcohol or drug dependency\n\nExclusion Criteria:\n\n* Inability to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT00178659', 'acronym': 'Proteomics', 'briefTitle': 'Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)', 'orgStudyIdInfo': {'id': 'HSC-MS-04-040'}, 'secondaryIdInfos': [{'id': 'N-13-04-040'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1 healthy volunteers', 'description': 'Healthy volunteers to act as controls - Recruitment is complete for this cohort', 'interventionNames': ['Other: Blood/saliva samples for protein/molecular analysis']}, {'label': '2 head trauma', 'description': 'Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort', 'interventionNames': ['Other: Blood/saliva samples for protein/molecular analysis']}, {'label': '3 orthopedic injury', 'description': 'The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:\n\n1. Fracture confirmed radiographically\n2. No head trauma\n3. No other known inflammatory process or infection\n4. No history of neurological or psychiatric disorders or alcohol or drug dependency', 'interventionNames': ['Other: Blood/saliva samples for protein/molecular analysis']}, {'label': '4 Mild TBI', 'description': 'The mild TBI patients will be defined as those admitted to the ED experiencing, - Recruitment is complete for this cohort\n\n1. Non-penetrating head trauma manifesting one or more of the following:\n\n * Loss of consciousness\n * Post-traumatic amnesia\n * Altered mental status\n * Focal neurologic deficits, seizure\n2. GCS\\> 12\n3. No abnormalities on CT other than contusion\n4. No operative Lesions\n5. Length of hospital stay \\< 48 hrs\n6. No other known inflammatory process or infection\n7. No history of neurological or psychiatric disorders or alcohol or drug dependency', 'interventionNames': ['Other: Blood/saliva samples for protein/molecular analysis']}], 'interventions': [{'name': 'Blood/saliva samples for protein/molecular analysis', 'type': 'OTHER', 'otherNames': ['blood samples', 'saliva samples'], 'description': '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)', 'armGroupLabels': ['1 healthy volunteers', '2 head trauma', '3 orthopedic injury', '4 Mild TBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Pramod Dash, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIRR/Mission Connect', 'class': 'OTHER'}, {'name': 'The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Neurosurgery', 'investigatorFullName': 'Georgene Hergenroeder', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}