Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 4:05 AM
Study NCT ID:
NCT06175650
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2022-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint', 'timeFrame': 'up to 30 days post-surgery', 'description': 'Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc'}, {'measure': 'Primary endpoint', 'timeFrame': 'up to 30 days post-surgery', 'description': 'incidence of cerebrovascualar accident with neurological sequelae (number of patients)'}, {'measure': 'Primary endpoint', 'timeFrame': 'up to 30 days post-surgery', 'description': 'incidence of acute kidney injury (number of patients)'}, {'measure': 'Primary endpoint', 'timeFrame': 'up to 30 days post-surgery', 'description': 'incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation \\> 48 hours post-operatively)'}, {'measure': 'Primary endpoint', 'timeFrame': 'up to 30 days post-surgery', 'description': 'Number of specific (coagulation), transfusion products,'}, {'measure': 'Primary outcome', 'timeFrame': 'up to 30 days post-surgery or if still in hospital, until discharge', 'description': 'Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.'}], 'secondaryOutcomes': [{'measure': 'Morbidity and mortality', 'timeFrame': 'At 30, 90, 365 days', 'description': 'peroperative and post-operative complications'}, {'measure': 'Survival', 'timeFrame': 'At 5 and 10 years', 'description': 'Long term survival'}, {'measure': 'Health related Quality of life measured by PROMS', 'timeFrame': 'At 1, 5 and 10 years', 'description': 'Long term quality of life after cardiac surgery, measured by Seattle Angina Questionaire (SAQ), EuroQol Quality of life (EQ-5D-5L) and Coronary Revascularisation Outcome Questionnaire (CROQ) or other appropriate questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Quality of Life'], 'conditions': ['Female', 'Male', 'Surgery,Cardiac']}, 'referencesModule': {'references': [{'pmid': '34606298', 'type': 'BACKGROUND', 'citation': 'Cho L, Kibbe MR, Bakaeen F, Aggarwal NR, Davis MB, Karmalou T, Lawton JS, Ouzounian M, Preventza O, Russo AM, Shroyer AW, Zwischenberger BA, Lindley KJ. Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care? Circulation. 2021 Oct 5;144(14):1172-1185. doi: 10.1161/CIRCULATIONAHA.121.056025. Epub 2021 Oct 4.'}, {'pmid': '34520795', 'type': 'BACKGROUND', 'citation': 'Dixon LK, Di Tommaso E, Dimagli A, Sinha S, Sandhu M, Benedetto U, Angelini GD. Impact of sex on outcomes after cardiac surgery: A systematic review and meta-analysis. Int J Cardiol. 2021 Nov 15;343:27-34. doi: 10.1016/j.ijcard.2021.09.011. Epub 2021 Sep 11.'}, {'pmid': '34776353', 'type': 'BACKGROUND', 'citation': 'Nanegrungsunk D, Patel S, Jan T, Ngai JY. Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists. J Cardiothorac Vasc Anesth. 2022 Mar;36(3):920-921. doi: 10.1053/j.jvca.2021.09.054. Epub 2021 Oct 3. No abstract available.'}, {'pmid': '34524421', 'type': 'BACKGROUND', 'citation': 'Peters SAE, Kluin J. Why do women do worse after coronary artery bypass grafting? Eur Heart J. 2021 Dec 28;43(1):29-31. doi: 10.1093/eurheartj/ehab617. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.', 'detailedDescription': 'Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available.\n\nIn addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of male and female patients, 18 years and older. The study group consists of all patients who underwent cardiac surgery from 1 January 2016 onwards, in either of the centres (AMC or VUmc). The registry will continue for at least 10 years after the inclusion of the last patient.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years\n* All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective)\n* All patients undergoing cardiac surgery from the start of the study (\\~March 2022) until approximately 2032\n\nExclusion Criteria:\n\n• Patients who object to the re-use of their care data or do not give consent'}, 'identificationModule': {'nctId': 'NCT06175650', 'acronym': 'F-ERAS', 'briefTitle': 'Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery\'\' (F-ERAS) Pathway:', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery\'\' (F-ERAS) Pathway: An Observational Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients', 'orgStudyIdInfo': {'id': 'W22_051 # 22.082'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female', 'description': 'Female patients undergoing cardiac surgery', 'interventionNames': ['Procedure: Cardiac surgery']}, {'label': 'Male', 'description': 'Male patients undergoing cardiac surgery', 'interventionNames': ['Procedure: Cardiac surgery']}], 'interventions': [{'name': 'Cardiac surgery', 'type': 'PROCEDURE', 'description': 'Cardiac surgery of all types', 'armGroupLabels': ['Female', 'Male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jennifer S Breel, MPA,MSc.', 'role': 'CONTACT', 'email': 'j.s.breel@amsterdamumc.nl', 'phone': '+316 1001 9257'}, {'name': 'Susanne Eberl, MD, PhD', 'role': 'CONTACT', 'email': 's.eberl@amsterdamumc.nl', 'phone': '+31205669111', 'phoneExt': '62533'}, {'name': 'Jennifer S Breel, MPA,MSc.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susanne Eberl, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Jennifer S Breel, MSc', 'role': 'CONTACT', 'email': 'j.s.breel@amsterdamumc.nl', 'phone': '+31610019257'}, {'name': 'Susanne Eberl, PhD', 'role': 'CONTACT', 'email': 's.eberl@amsterdamumc.nl', 'phone': '+31610019257'}], 'overallOfficials': [{'name': 'Markus W Hollmann, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology and Pain Medicine, Amsterdam Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Breel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Jennifer Breel', 'investigatorAffiliation': 'Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)'}}}}