Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT03484104
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebral Perfusion in Hypothermic Circulatory Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TOI', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake.'}], 'secondaryOutcomes': [{'measure': 'Vmca', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The secondary outcome is the mean blood flow velocity in the middle cerebral artery at sACP the specified flow rates in comparison to the VmMCA during general anesthesia, after anesthesia induction.'}, {'measure': 'Neurologic accidents', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'An additional secondary outcome measure are any neurologic accidents during the same hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass', 'Hypothermic circulatory arrest', 'Aortic arch surgery'], 'conditions': ['Cerebrovascular Circulation']}, 'descriptionModule': {'briefSummary': 'Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population scheduled for elective aortic arch surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Elective cardiac surgery with cardiopulmonary bypass\n* Hypothermic circulatory arrest\n* General informed consent signed\n\nExclusion Criteria:\n\n\\- Severe stenotis in cerebral arteries'}, 'identificationModule': {'nctId': 'NCT03484104', 'briefTitle': 'Cerebral Perfusion in Hypothermic Circulatory Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest', 'orgStudyIdInfo': {'id': '2017-02216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypothermic circulatory arrest', 'description': 'Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion', 'interventionNames': ['Diagnostic Test: Measurement of tissue oxygenation index (TOI)']}], 'interventions': [{'name': 'Measurement of tissue oxygenation index (TOI)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Measurement of mean blood flow velocity in the middle cerebral artery (Vmca)'], 'description': 'TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest', 'armGroupLabels': ['Hypothermic circulatory arrest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, University Hospital Bern, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Gabor Erdoes, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Gabor Erdös', 'investigatorAffiliation': 'Insel Gruppe AG, University Hospital Bern'}}}}