Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT04956835
Status:
UNKNOWN
Last Update Posted:
2021-07-09
First Post:
2021-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2021-06-26', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications according to Clavien-Dindo classification', 'timeFrame': 'within two weeks after surgery', 'description': 'Grade 0 to V (0 no complication, V death)'}, {'measure': 'Comprehensive Complication Index', 'timeFrame': 'within two weeks after surgery', 'description': 'Based on Clavien-Dindo classification with a scale from 0 to 100 (0 no complication, 100 death)'}, {'measure': 'Neurological status', 'timeFrame': 'within two weeks after surgery', 'description': 'classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale'}, {'measure': 'Neurological outcome (NANO scale)', 'timeFrame': 'within two weeks after surgery', 'description': 'according to neurological assessment in neuro-oncology (NANO) with a scale from 0 to 23 (0 no neurological deficit, 23 multiple neurological deficits)'}, {'measure': 'Neurological outcome (NIHSS)', 'timeFrame': 'within two weeks after surgery', 'description': 'according to National Institutes of Health Stroke Scale (0 no stroke symptoms 1-4 minor stroke 5-15 moderate stroke 16-20 moderate to severe stroke 21-42 severe stroke)'}, {'measure': 'Neurological outcome (mRS)', 'timeFrame': 'within two weeks after surgery', 'description': 'according to modified Rankin Scale with a scale from 0 to 6 (0 no symptoms, 6 dead)'}, {'measure': 'In-hospital mortality', 'timeFrame': 'within two weeks after surgery', 'description': 'Death of the patient'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': 'within two weeks after surgery'}, {'measure': 'Length of hospital stay', 'timeFrame': 'within two weeks after surgery'}, {'measure': 'Readmission rate', 'timeFrame': 'within 90 days after surgery', 'description': 'Readmission to hospital after discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurological Morbidity', 'Surgical Complication', 'Anesthesia Morbidity']}, 'referencesModule': {'references': [{'pmid': '32843333', 'type': 'BACKGROUND', 'citation': "Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917."}, {'pmid': '37407852', 'type': 'DERIVED', 'citation': 'Drexler R, Ricklefs FL, Pantel T, Gottsche J, Nitzschke R, Zollner C, Westphal M, Duhrsen L. Association of the classification of intraoperative adverse events (ClassIntra) with complications and neurological outcome after neurosurgical procedures: a prospective cohort study. Acta Neurochir (Wien). 2023 Aug;165(8):2015-2027. doi: 10.1007/s00701-023-05672-w. Epub 2023 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'In the planned study, the ClassIntra score will be assessed after all neurosurgical procedures in the upcoming 6 months and correlated with all pre- and postoperative data. Afterwards, the conclusion will be made, if the ClassIntra score could predict the postoperative course of the patients regarding their neurological and general condition. Furthermore, analyses will be made to develop novel postoperative routines adjusted to the individual ClassIntra score of the patient.', 'detailedDescription': 'Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. As there are well-defined scores and classifications to describe the postoperative course regarding morbidity, mortality and neurological status, no validated classification for intraoperative quality exists by now. However, Dell-Kuster et al. introduced a novel classification for assessing all intraoperative adverse events: ClassIntra. This classification was developed in a Delphi consensus containing international, interdisciplinary, and validated in a multicentre cohort study across all surgical disciplines. The classification defines intraoperative adverse events as any deviation from the ideal intraoperative course occurring between skin incision and skin closure and contains any event related to surgery and anaesthesia. Depending on the kind of adverse event, the ClassIntra score ranges from 0 (no event) to 5 (intraoperative death). A prospective study with a main focus on neurosurgery covering the whole spectrum of elective and emergency procedures is needed. Hereby, the outcome parameters need to be defined specific for neurosurgical procedures including a preoperative and postoperative neurological status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgery at a neurosurgical department either elective or emergency surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgery at a neurosurgical department\n\nExclusion Criteria:\n\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT04956835', 'briefTitle': 'The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures', 'orgStudyIdInfo': {'id': 'CINS'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hambrug', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Richard Drexler, MD', 'role': 'CONTACT', 'email': 'r.drexler@uke.de'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Richard Drexler, MD', 'role': 'CONTACT', 'email': 'r.drexler@uke.de', 'phone': '+4915222816461'}, {'name': 'Lasse Dührsen, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Richard Drexler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Drexler', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}