Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT00364494
Status:
TERMINATED
Last Update Posted:
2009-08-14
First Post:
2006-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodilution and Outcome in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'whyStopped': 'difficult enrollment after the primary investigator left the centre', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-13', 'studyFirstSubmitDate': '2006-08-11', 'studyFirstSubmitQcDate': '2006-08-11', 'lastUpdatePostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal function'}], 'secondaryOutcomes': [{'measure': 'other organ damage'}, {'measure': 'prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay'}, {'measure': 'sepsis'}, {'measure': 'exitus'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hematocrit', 'Hemodilution', 'Blood Transfusion', 'Cardiopulmonary Bypass', 'Multiple Organ Failure', 'Surgery, Cardiac', 'Kidney Failure', 'Cardiac Surgical Procedures'], 'conditions': ['Kidney Failure', 'Intraoperative Complications']}, 'descriptionModule': {'briefSummary': 'An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery.\n\nThe investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing cardiac surgery\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Not signing written consent\n* Age \\< 65 years old (subgroup 1)\n* Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)'}, 'identificationModule': {'nctId': 'NCT00364494', 'briefTitle': 'Hemodilution and Outcome in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery', 'orgStudyIdInfo': {'id': 'DS/URC/ER/mm 556/DG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)', 'type': 'PROCEDURE', 'description': 'Subgroup 1,with Ht\\<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht\\>25% bleed or not'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Giovanni Landoni, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia'}, {'name': 'Giuseppe Crescenzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}}}}