Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
Study NCT ID:
NCT04291066
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2019-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-22', 'mcpReleaseN': 3, 'releaseDate': '2024-06-27'}, {'resetDate': '2024-12-26', 'mcpReleaseN': 4, 'releaseDate': '2024-12-05'}, {'resetDate': '2025-02-14', 'mcpReleaseN': 5, 'releaseDate': '2025-01-27'}], 'estimatedResultsFirstSubmitDate': '2024-06-27'}}, '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': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D008903', 'term': 'Minerals'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine improvement in somatic, cognitive, and emotional post-concussion symptoms as measured by the Rivermeade Post-concussion Questionnaire (RPQ) in treatment group vs non-treatment group.', 'timeFrame': '1 to 30 days post traumatic brain injury event', 'description': 'Somatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission, post injury day 7, and post injury day 30. The scale goes based on a zero to 4 grading system. Zero equaling "not experienced at all" to 4 equaling "a severe problem".'}], 'secondaryOutcomes': [{'measure': 'Severity of common post TBI symptoms', 'timeFrame': '1 to 30 days post traumatic brain injury event', 'description': 'The severity of the five most common post TBI symptoms, including headache, nausea, sleep disturbance, poor concentration and forgetfulness/poor memory as measured by the scores of individual questions in the Rivermeade Post-concussion Questionnaire within 24 hours of admission, post injury day 7, and post injury day 30. Scale is 0 to 64'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '35393384', 'type': 'DERIVED', 'citation': 'Mcpherson RA, Mangram AJ, Barletta JF, Dzandu JK. N -acetylcysteine is associated with reduction of postconcussive symptoms in elderly patients: A pilot study. J Trauma Acute Care Surg. 2022 Nov 1;93(5):644-649. doi: 10.1097/TA.0000000000003639. Epub 2022 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the administration of N-Acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (\\>60 years of age) who have experienced a traumatic brain injury.', 'detailedDescription': 'This study aims to determine the effect of supplemental N-acetyl cysteine and additional multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms as determined by the Rivermeade Post-concussion Questionnaire (RPQ) within 24 hours of admission, post injury day 7, and post injury day 30. The RPQ questionnaires will be given to patients older than 60 years, who have been evaluated by the HonorHealth John C. Lincoln Medical Center or Deer Valley Medical Center trauma service within 3 hours of sustaining a traumatic brain injury (TBI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years or older\n* present to emergency department within 3 hours of documented TBI\n\nExclusion Criteria:\n\n* patients without TBI\n* patients with a history of TBI greater than 3 hours prior to presentation\n* patients under the age of 60\n* currently enrolled in an ongoing research study\n* patients who at baseline prior to the TBI, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to TBI)\n* Patients who are unable to tolerate PO medications within 3 hours of sustaining TBI.'}, 'identificationModule': {'nctId': 'NCT04291066', 'briefTitle': 'Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'HonorHealth Research Institute'}, 'officialTitle': 'Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients', 'orgStudyIdInfo': {'id': '1445221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'oral N-acetyl cysteine and oral multivitamin tablets', 'interventionNames': ['Drug: N-Acetyl cysteine']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Treatment', 'description': 'Routine Care'}], 'interventions': [{'name': 'N-Acetyl cysteine', 'type': 'DRUG', 'otherNames': ['Multi-vitamins with minerals'], 'description': 'Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth John C. Lincoln Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Deer Valley Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Ryab mcPherson, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HonorHealth Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be published in peer-reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HonorHealth Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}