Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-07 @ 7:11 AM
Study NCT ID:
NCT02835703
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2016-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001017', 'term': 'Aortic Coarctation'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events in early postoperative period', 'timeFrame': '30 days after surgery', 'description': 'Number of participants with adverse events that are related to treatment (including hospital mortality, renal injury (pRIFLE criteria), neurological complications (confirmed by CT or MRI) )'}], 'secondaryOutcomes': [{'measure': 'Degree of inotropic support (inotropic score)', 'timeFrame': 'through ICU stay, an average of 3 weeks'}, {'measure': 'Intraoperative blood loss (ml)', 'timeFrame': 'intraoperatively'}, {'measure': 'Temperature of cooling (C)', 'timeFrame': 'intraoperatively'}, {'measure': 'Duration of CPB (min)', 'timeFrame': 'intraoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Congenital heart disease', 'Coarctation of aorta', 'Aortic arch hypoplasia', 'Cerebral selective antegrade perfusion', 'Double arterial cannulation'], 'conditions': ['Coarctation of Aorta']}, 'referencesModule': {'references': [{'pmid': '32446921', 'type': 'DERIVED', 'citation': 'Kulyabin YY, Bogachev-Prokophiev AV, Soynov IA, Omelchenko AY, Zubritskiy AV, Gorbatykh YN. Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):860-871. doi: 10.1053/j.semtcvs.2020.04.015. Epub 2020 May 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.', 'detailedDescription': 'Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* coarctation with severe aortic arch hypoplasia (distal aortic arch z-score \\< -2)\n* coarctation of aorta with septal defects\n\nExclusion Criteria:\n\n* coarctation with mild aortic arch hypoplasia (distal aortic arch z-score \\> -2)\n* complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, Shone's complex)\n* univentricular and duct-dependent heart defects\n* aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score \\< -2.0)\n* left ventricular dysfunction (left ventricle ejection fraction \\< 60%)\n* congenital renal or central nervous system anomalies\n* related infectious diseases\n* prematurity (gestational age \\< 37 weeks)"}, 'identificationModule': {'nctId': 'NCT02835703', 'briefTitle': 'Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants', 'orgStudyIdInfo': {'id': 'PTAAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Deep hypothermic arrest', 'description': 'Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest', 'interventionNames': ['Procedure: Surgical repair of coarctation of aorta']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Selective antegrade cerebral perfusion', 'description': 'Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion', 'interventionNames': ['Procedure: Surgical repair of coarctation of aorta']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double arterial cannulation', 'description': 'Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation', 'interventionNames': ['Procedure: Surgical repair of coarctation of aorta']}], 'interventions': [{'name': 'Surgical repair of coarctation of aorta', 'type': 'PROCEDURE', 'description': 'Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB', 'armGroupLabels': ['Deep hypothermic arrest', 'Double arterial cannulation', 'Selective antegrade cerebral perfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yuriy Y Kulyabin, MD', 'role': 'CONTACT', 'email': 'y.y.coolyabin@gmail.com', 'phone': '+79538889890'}, {'name': 'Yuriy Y Kulyabin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuriy N Gorbatykh, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Yuriy Y Kulyabin, MD', 'role': 'CONTACT', 'email': 'y.y.coolyabin@gmail.com', 'phone': '+79538889890'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}