Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04682951
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2020-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020767', 'term': 'Intracranial Thrombosis'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'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'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D020521', 'term': 'Stroke'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056424', 'term': 'Decompressive Craniectomy'}], 'ancestors': [{'id': 'D019299', 'term': 'Decompression, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003399', 'term': 'Craniotomy'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good neurological outcome', 'timeFrame': '6 months after surgery', 'description': 'The neurological outcome is considered "good" when Glasgow Outcome Score extended (GOSE) assessed 6 months after decompressive craniectomy is between 5 and 8.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decompressive craniectomy', 'Outcome', 'Brain injuries', 'Aneurysmal subarachnoid hemorrhage', 'Cerebral venous thrombosis', 'Intracerebral hemorrhage', 'Ischemic stroke', 'Traumatic brain injury'], 'conditions': ['Decompressive Craniectomy', 'Brain Injuries', 'Treatment Outcome']}, 'descriptionModule': {'briefSummary': 'Decompressive craniectomy is a treatment of refractory intracranial hypertension after various etiologies : malignant ischemic stroke, traumatic brain injury, intraparenchymal hemorrhage, aneurysmal subarachnoid hemorrhage, cerebral venous thrombosis.\n\nInitially considered as a lifesaving therapy, benefits in terms of survival were shown compared to medical treatment alone.\n\nHowever, despite a better survival, morbidity and poor neurological outcome are frequent among survivors.\n\nThe objective of the study is to identify initial good neurological outcome factors after decompressive craniectomy in a large series of patients, in order to argue surgical and intensive care decisions, considering expected benefit and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing a decompressive craniectomy on a 10 year period in CHRU Nancy, France.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in CHRU Nancy, France.\n\nExclusion Criteria:\n\n* Infectious ou malignant disease leading to decompressive craniectomy.'}, 'identificationModule': {'nctId': 'NCT04682951', 'briefTitle': 'Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study', 'orgStudyIdInfo': {'id': '2020PI244'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Decompressive Craniectomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'University Hospital of Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'AUDIBERT Gérard', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}