Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT04522856
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002545', 'term': 'Brain Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological outcome 90 days after the stroke', 'timeFrame': '90 days', 'description': 'Neurological outcome is measured using the modified Rankin Scale \\[0-6\\], with higher values indicating worse outcome. As a Primary Outcome Measure, the scale will be dichotomized into good (modified Rankin Scale ≤ 2) versus poor (modified Rankin Scale \\> 2) outcome.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'Mortality rate 90 days after the stroke. Mortality rate is the percentage of patients that have died within 90 days following their stroke.'}, {'measure': 'Grade of recanalization', 'timeFrame': 'sixty minutes', 'description': 'Recanalization is classified according to the modified Thrombolysis in Cerebral Infarction classification (mTICI) \\[0 - 3\\], with higher values indicating better reperfusion.'}, {'measure': 'Duration', 'timeFrame': '30 Minutes', 'description': "Duration \\[minutes\\] from patient's arrival in angiography suite to arterial puncture for endovascular thrombectomy.\n\nDuration \\[minutes\\] from patient's arrival in angiography suite to arterial puncture for endovascular thrombectomy.\n\nDuration \\[minutes\\] from arterial puncture to end of endovascular thrombectomy."}, {'measure': 'Proportion of patients breathing spontaneously', 'timeFrame': 'sixty minutes', 'description': 'Proportion of patients breathing spontaneously after thrombectomy \\[Time Frame: On transfer from angiography suite after thrombectomy, which typically takes 1 hour\\]. This is defined as percentage of patients that breathe spontaneously without laryngeal mask, laryngeal tube, or endotracheal tube after thrombectomy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endovascular thrombectomy', 'acute ischaemic stroke', 'large-vessel occlusion'], 'conditions': ['Cerebral Ischemia']}, 'descriptionModule': {'briefSummary': 'Endovascular thrombectomy is the standard of care for acute ischaemic stroke due to large-vessel occlusion. Current guidelines for periprocedural anaesthesiological care give gross recommendations on management of stroke patients during recanalization, but lack detailed information.\n\nTo determine how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique, choice of substances, haemodynamic management, and ventilation. With a multivariate analysis, the investigators will look for the factors of anesthetic management that are independently correlated with a good or bad outcome.', 'detailedDescription': 'see brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population consists of patients undergoing emergency endovascular thrombectomy for treatment of AIS-LVO. The planned minimum sample size is 5,000 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endovascular stroke treatment involving anaesthesia care\n\nExclusion Criteria:\n\n* In-hospital onset of stroke\n* Inclusion in an interventional study concerning the anaesthesia protocol\n* Age under 18 years'}, 'identificationModule': {'nctId': 'NCT04522856', 'briefTitle': 'Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia', 'organization': {'class': 'OTHER', 'fullName': 'European Society of Anaesthesiology'}, 'officialTitle': 'Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia', 'orgStudyIdInfo': {'id': 'ARCTIC-I'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular thrombectomy', 'description': 'there is only one group of the subjects that had stroke and went under thrombectomy procedure and to see how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique,choice of substances, haemodynamic management, and ventilation.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'ESAIC', 'role': 'CONTACT'}], 'facility': 'TU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Andreas Ranft, Dr.', 'role': 'CONTACT', 'email': 'andreas.ranft@tum.de', 'phone': '004989 4140 9632'}], 'overallOfficials': [{'name': 'Andreas Ranft, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Senior Physician-München, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Society of Anaesthesiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}