Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01565967
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2011-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry AutoLog Lipid Removal and Blood Component Characterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and washed blood will be collected from each patient'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of reduction of nonemulsified fat', 'timeFrame': 'after process', 'description': 'The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AutoLog', 'Post market release', 'Non-interventional'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives:\n\n1. to determine the lipid removal capabilities of the Medtronic AutoLog System.\n2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.', 'detailedDescription': 'Since the in house data strongly suggest that the Medtronic AutoLog is uniquely high performing in lipid removal in-vitro, the Registry AutoLog Lipid Removal and Blood Component Characterization is initiated to determine if the AutoLog system is successful in removing lipids in vivo as it is in-vitro. Therefore, it is expected that the lipid amounts after washing will be less than 10 mg/dl.\n\nThe study is designed as a multi-center, non-randomized, non-interventional, post market release study (a registry). The study has a single arm, without controls, as it is descriptive in nature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subject population includes all subjects with an indication for cardiac surgery, orthopedic surgery etc. in which the hospital treatment protocol requires the routine use of an autotransfusion system, and who meet the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an indication for surgery procedures in which the hospital treatment protocol requires the routine use of an autotransfusion system are eligible for participation.\n\nExclusion Criteria:\n\n* The use of citrate-based anticoagulant in patients with impaired liver function\n* Gross contamination and/or septic procedures\n* Surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system\n* Caesarean sections in presence of amniotic fluid\n* Presence of high concentrations of prostatic fluid\n* Contamination of salvaged blood with drugs not intended for intravenous administration\n* Use of collagen-based haemostatic agents and gel foam used in combination with any autotransfusion system\n* Coagulopathy\n* Not willing to sign a Patient Informed Consent/Data Release Form'}, 'identificationModule': {'nctId': 'NCT01565967', 'briefTitle': 'Registry AutoLog Lipid Removal and Blood Component Characterization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Registry AutoLog Lipid Removal and Blood Component Characterization', 'orgStudyIdInfo': {'id': 'AutoLog'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autotransfusion', 'description': 'All patients undergoing surgery which requires routine use of an autotransfusion system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Materdomini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '08861', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santariskiu Klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '1210', 'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}, {'zip': '1007MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '0002', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Zuid-Afrikaans Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Universitetssjukhuset i Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}