Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-28 @ 11:35 PM
Study NCT ID:
NCT05807503
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury
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': 'C006952', 'term': 'cerebrolysin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glasgow Outcome Scale GOS', 'timeFrame': '2 months', 'description': 'Glasgow Outcome Scale'}, {'measure': 'Length Of Stay LOS', 'timeFrame': '2 months', 'description': 'Length Of Stay'}, {'measure': 'Mortality', 'timeFrame': '2 months', 'description': 'Death of the patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TBI', 'neuroprotective treatment', 'Cerebrolysin', 'neuromonitoring', 'NIRS', 'ICP', 'ONDS'], 'conditions': ['TBI (Traumatic Brain Injury)']}, 'descriptionModule': {'briefSummary': "Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '56 patients in age from 28 to 91 years old, 33% female, 66% male, bleeding during the TBI:\n\n* epidural: 16/56 (27%)\n* subdural : 26/56 (45%)\n* into deep structures: 14/56 (23%)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TBI diagnosis\n* admission to ICU\n* age \\>18 y\n\nExclusion Criteria:\n\n* initially lethal injury\n* age \\<18 y'}, 'identificationModule': {'nctId': 'NCT05807503', 'briefTitle': 'Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Pomeranian Medical University Szczecin'}, 'officialTitle': 'Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial', 'orgStudyIdInfo': {'id': '02/10/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A with Cerebrolysin administration', 'description': 'Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated with Cerebrolysin administration in addition to standard ICU protocols.', 'interventionNames': ['Drug: Cerebrolysin']}, {'label': 'B without Cerebrolysin administration', 'description': 'Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated without Cerebrolysin administration according to standard ICU protocols.'}], 'interventions': [{'name': 'Cerebrolysin', 'type': 'DRUG', 'description': 'Cerebrolysin administration in short period of time after TBI', 'armGroupLabels': ['A with Cerebrolysin administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70-204', 'city': 'Szczecin', 'state': 'West Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Pomeranian Medical University', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}], 'overallOfficials': [{'name': 'Konrad Jarosz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Department Of Specialist Nursing, Pomeranian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'more information after individual contacting with investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pomeranian Medical University Szczecin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Klaudyna Kojder', 'investigatorAffiliation': 'Pomeranian Medical University Szczecin'}}}}