Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-23 @ 12:53 AM
Study NCT ID:
NCT01247051
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2010-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-26', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Inflammatory response', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['priming', 'cardiac surgery', 'cardio pulmonary bypass', 'precoating'], 'conditions': ['Priming', 'Cardiac Surgery', 'Cardio Pulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'The study is a single-center, randomized, un-blinded treatment study in which patients (\\>78 years) with the use off a heart-lung machine were provided into two study arms.\n\nPatient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '78 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 78 years\n* CPB\n\nExclusion Criteria:\n\n* Hb \\<12 mg/dl\n* Off pump surgery'}, 'identificationModule': {'nctId': 'NCT01247051', 'briefTitle': 'Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'orgStudyIdInfo': {'id': 'PRE001AHK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precoating', 'interventionNames': ['Procedure: Precoating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard priming', 'interventionNames': ['Procedure: Standard priming']}], 'interventions': [{'name': 'Precoating', 'type': 'PROCEDURE', 'description': 'preoperative filling of heart lung machine with patients blood', 'armGroupLabels': ['Precoating']}, {'name': 'Standard priming', 'type': 'PROCEDURE', 'description': 'preoperative filling of heart lung machine with colloids', 'armGroupLabels': ['Standard priming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head cardiovascular research', 'investigatorFullName': 'Arndt-H. Kiessling', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}