Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT05767502
Status:
UNKNOWN
Last Update Posted:
2023-03-14
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MORTALITY', 'timeFrame': 'From admission to discharge, an average of 1 weeks', 'description': 'Death of the patient while in the hospital'}, {'measure': 'MORBIDTIY', 'timeFrame': 'From admission to discharge, an average of 1 weeks', 'description': 'Patients with a Glasgow Outcome score of 2 and 3 (Each patient can get 1-5 points from the Glasgow Outcome score. A low score indicates a negative result.'}], 'secondaryOutcomes': [{'measure': 'MORTALITY', 'timeFrame': '3 months after hospital discharge', 'description': 'Death within 3 months after hospital discharge'}, {'measure': 'MORBIDITY', 'timeFrame': '3 months after hospital discharge', 'description': 'A Glaskow Coma Outcome Score of 2 and 3 at the end of 3 months after discharge from the hospital. (Each patient can get 1-5 points from the Glasgow Outcome score. A low score indicates a negative result)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GCS', 'GCS-Pupil score', 'Brain trauma', 'Consciousness'], 'conditions': ['Brain Injuries, Traumatic']}, 'descriptionModule': {'briefSummary': 'In this study, it is aimed to determine the prognostic value of GCS-P and the GCS-P score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated. In the model to be created, a new total score will be obtained with Motor score + Eye Response + assigned verbal Score-Pupil score and this score will be compared with GCS and GCS-Pupil score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'When α: 0.05 β: 0.20 and the acceptable difference between models were selected as 10% using the G-Power program, the number of patients to be included in the study was determined as 199.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to hospital due to traumatic brain injury,\n* 18 years and older,\n* who were alive at the time of admission,\n* Patients whose GCS and pupil reactivity can be evaluated completely.\n\nExclusion Criteria:\n\n* Younger than 18,\n* Not alive at the time of admission,\n* Patients whose GCS score and pupil reactivity are not correctly evaluated (facial trauma, past eye diseases or eye defects, etc.).'}, 'identificationModule': {'nctId': 'NCT05767502', 'briefTitle': 'Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale', 'organization': {'class': 'OTHER', 'fullName': 'Uludag University'}, 'officialTitle': 'Investigation of the Effect of Assigning Verbal Component Score to Glasgow Coma Scale in Patients With Traumatic Brain Injury and Adding Pupil Reaction to Determining Mortality/Morbidity in Patients', 'orgStudyIdInfo': {'id': '2019-KAEK-140'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GCS-Pupil score', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['GCS+attributed verbal score- Pupil score'], 'description': 'GCS+attributed verbal score- Step 1 to obtain pupillary score:\n\n* Patients with a motor (M) and eye-opening response (E) total score between 2 and 6 are assigned a verbal score of +1\n* Patients with an M+E score of 7 are assigned a verbal score of +2\n* Patients with an M+E score of 8-9 are assigned a verbal score of +4\n* Patients with an M+E score of 10 are assigned a verbal score of +5\n\nGCS+attributed verbal score- Step 2 to obtain the pupillary score:\n\nThe total score is obtained by subtracting the pupil score from the score obtained in the 1st step. Pupil score is scored as follows;\n\n* 0 points if both pupils react to light,\n* 1 point if a pupil does not react to light and has anisocoria,\n* 2 points if both pupils do not react to light'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16000', 'city': 'Bursa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'BURSA CITY HOSPITAL ethics committee, ethics', 'role': 'CONTACT', 'email': 'bursasehir@saglik.gov.tr', 'phone': '02249750000', 'phoneExt': '1150'}], 'facility': 'Bursa City Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing of study data is not allowed in our country.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uludag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'AKİF BULUT', 'investigatorAffiliation': 'Uludag University'}}}}