Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-25 @ 12:58 AM
Study NCT ID:
NCT00600704
Status:
COMPLETED
Last Update Posted:
2011-06-07
First Post:
2008-01-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058734', 'term': 'Exsanguination'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'theoath1@gmail.com', 'phone': '00306948481865', 'title': 'Dr Athina Kleitsaki', 'organization': 'Larissa University Hospital Dept. of Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'RESTRICTED FLUIDS', 'description': 'Infusion of Hes 130/0.4 up to 500 ml', 'otherNumAtRisk': 100, 'otherNumAffected': 2, 'seriousNumAtRisk': 100, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'FREE FLUIDS', 'description': 'Free fluid infusion unless Hb\\< 6g/dl(allogenic blood use)', 'otherNumAtRisk': 92, 'otherNumAffected': 2, 'seriousNumAtRisk': 92, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'reoperation for bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'myocardial infraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'persistent significant arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'low output syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'persistent neurological dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lower extremity ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Packed Red Cells Units Transfused During Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'units': 'PRC Units', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RESTRICTED FLUIDS', 'description': 'Infusion of Hes 130/0.4 up to 500 ml'}, {'id': 'OG001', 'title': 'FREE FLUIDS', 'description': 'Free fluid infusion unless Hb\\< 6g/dl(allogenic blood use)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.36'}, {'value': '1.91', 'groupId': 'OG001', 'lowerLimit': '1.63', 'upperLimit': '2.19'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.379', 'ciLowerLimit': '0.189', 'ciUpperLimit': '0.569', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.096', 'groupDescription': 'Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.797', 'ciLowerLimit': '0.465', 'ciUpperLimit': '1.129', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.168', 'estimateComment': 'The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.', 'groupDescription': 'Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '20 months', 'unitOfMeasure': 'packed red cells units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'PRC Units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RESTRICTED FLUIDS', 'description': 'Infusion of Hes 130/0.4 up to 500 ml'}, {'id': 'FG001', 'title': 'FREE FLUIDS', 'description': 'Free fluid infusion unless Hb\\< 6g/dl(allogenic blood use)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This prospective study was conducted in our University Hospital over a 20-month period, after approval from the Institution Ethics committee, and written informed consent was obtained from all patients before entering the study. All the participants were patients of the Cardio-Thoracic Clinic of our Hospital.', 'preAssignmentDetails': 'Exclusion criteria were emergency or re-do operations, operations starting after 18.00, administration of tissue plasminogen activator (TPA) or other thrombolytic medications, pre-existing hematologic disease or coagulation abnormality, advanced cirrhosis, renal failure, preoperative blood product transfusion, combined cardiac and carotid surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RESTRICTED FLUIDS', 'description': 'Infusion of Hes 130/0.4 up to 500 ml'}, {'id': 'BG001', 'title': 'FREE FLUIDS', 'description': 'Free fluid infusion unless Hb\\< 6g/dl(allogenic blood use)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '65.77', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-09', 'studyFirstSubmitDate': '2008-01-14', 'resultsFirstSubmitDate': '2011-03-04', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-09', 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Packed Red Cells Units Transfused During Hospital Stay', 'timeFrame': '20 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allogenic Blood Use', 'Total Blood Loss', 'Reinfusion of Washed Shed Blood'], 'conditions': ['Coronary Artery Disease', 'Coronary Artery Bypass', 'Erythrocyte Transfusion']}, 'referencesModule': {'references': [{'pmid': '17462454', 'type': 'BACKGROUND', 'citation': 'Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007 May;83(5 Suppl):S27-86. doi: 10.1016/j.athoracsur.2007.02.099.'}, {'pmid': '16153909', 'type': 'BACKGROUND', 'citation': 'Dial S, Delabays E, Albert M, Gonzalez A, Camarda J, Law A, Menzies D. Hemodilution and surgical hemostasis contribute significantly to transfusion requirements in patients undergoing coronary artery bypass. J Thorac Cardiovasc Surg. 2005 Sep;130(3):654-61. doi: 10.1016/j.jtcvs.2005.02.025.'}, {'pmid': '9477051', 'type': 'BACKGROUND', 'citation': "Stover EP, Siegel LC, Parks R, Levin J, Body SC, Maddi R, D'Ambra MN, Mangano DT, Spiess BD. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology. 1998 Feb;88(2):327-33. doi: 10.1097/00000542-199802000-00009."}, {'pmid': '16181875', 'type': 'BACKGROUND', 'citation': 'Karkouti K, Djaiani G, Borger MA, Beattie WS, Fedorko L, Wijeysundera D, Ivanov J, Karski J. Low hematocrit during cardiopulmonary bypass is associated with increased risk of perioperative stroke in cardiac surgery. Ann Thorac Surg. 2005 Oct;80(4):1381-7. doi: 10.1016/j.athoracsur.2005.03.137.'}, {'pmid': '12830066', 'type': 'BACKGROUND', 'citation': 'Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ, Shah A. Adverse effects of low hematocrit during cardiopulmonary bypass in the adult: should current practice be changed? J Thorac Cardiovasc Surg. 2003 Jun;125(6):1438-50. doi: 10.1016/s0022-5223(02)73291-1.'}, {'pmid': '11269449', 'type': 'BACKGROUND', 'citation': "DeFoe GR, Ross CS, Olmstead EM, Surgenor SD, Fillinger MP, Groom RC, Forest RJ, Pieroni JW, Warren CS, Bogosian ME, Krumholz CF, Clark C, Clough RA, Weldner PW, Lahey SJ, Leavitt BJ, Marrin CA, Charlesworth DC, Marshall P, O'Connor GT. Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting. Northern New England Cardiovascular Disease Study Group. Ann Thorac Surg. 2001 Mar;71(3):769-76. doi: 10.1016/s0003-4975(00)02393-6."}, {'pmid': '20187484', 'type': 'DERIVED', 'citation': 'Vretzakis G, Kleitsaki A, Stamoulis K, Dragoumanis C, Tasoudis V, Kyriakaki K, Mikroulis D, Giannoukas A, Tsilimingas N. The impact of fluid restriction policy in reducing the use of red blood cells in cardiac surgery. Acta Anaesthesiol Belg. 2009;60(4):221-8.'}, {'pmid': '20181257', 'type': 'DERIVED', 'citation': 'Vretzakis G, Kleitsaki A, Stamoulis K, Bareka M, Georgopoulou S, Karanikolas M, Giannoukas A. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial. J Cardiothorac Surg. 2010 Feb 24;5:7. doi: 10.1186/1749-8090-5-7.'}]}, 'descriptionModule': {'briefSummary': "The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.", 'detailedDescription': '192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, "extra" volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. "Transfusion" was analyzed as a categorical characteristic. Analysis employed Student\'s two-tailed t-test, t-paired test and chitest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ejection fraction (EF) of left ventricle (LV) \\> 35%\n* Preoperative serum Creatinine \\< 150 μmol/l\n* Preoperative Haemoglobin \\> 10/dl\n* Peripheral anastomosis scheduled =\\< 3\n\nExclusion Criteria:\n\n* redo bypass-emergency operations\n* prior coronal stenting\n* active congestive heart failure\n* documented Myocardial Infraction within the previous 6 weeks\n* NYHA class \\> 3\n* Carotid stenosis \\> 50%\n* CVA\n* INR \\> 1.5\n* chronic obstructive pulmonary disease (COPD)\n* Steroid therapy-chronic inflammatory process\n* Use of aprotinin or tranexamic acid'}, 'identificationModule': {'nctId': 'NCT00600704', 'briefTitle': 'Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': 'Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'LUH 1975 AK'}, 'secondaryIdInfos': [{'id': 'POL 1969 TT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RESTRICTED FLUIDS', 'description': 'Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass', 'interventionNames': ['Procedure: Fluid Restriction Policy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FREE FLUIDS', 'description': 'Free fluid infusion unless Hb\\< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass', 'interventionNames': ['Procedure: Free fluid infusion']}], 'interventions': [{'name': 'Fluid Restriction Policy', 'type': 'PROCEDURE', 'description': 'Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass', 'armGroupLabels': ['RESTRICTED FLUIDS']}, {'name': 'Free fluid infusion', 'type': 'PROCEDURE', 'description': 'Free fluid infusion unless Hb\\< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass', 'armGroupLabels': ['FREE FLUIDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thesalia', 'country': 'Greece', 'facility': 'Larissa University Hospital', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'ATHINA KLEITSAKI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larissa University Hospital'}, {'name': 'GEORGE VRETZAKIS, M.D. PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece'}, {'name': 'KONSTANTINOS STAMOULIS, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece'}, {'name': 'CHRISTOS DRAGOUMANIS, M.D. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece'}, {'name': 'VASILIOS TASOUDIS, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece'}, {'name': 'KATERINA KYRIAKAKI, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece'}, {'name': 'DEMETRIOS MIKROULIS, M.D. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece'}, {'name': 'ATHANASIOS GIANNOUKAS, MD MSc PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Vascular Surgery, University Hospital of Larissa, Greece'}, {'name': 'NIKOLAOS TSILIMINGAS, M.D. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'ATHINA KLEITSAKI', 'oldOrganization': 'LARISSA UNIVERSITY HOSPITAL/DPT OF ANESTHESIOLOGY'}}}}