Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-02 @ 12:30 AM
Study NCT ID:
NCT01462968
Status:
WITHDRAWN
Last Update Posted:
2015-06-26
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study never started due to problems with Laboratory facilities in collaborating center', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-31', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta Thrombingeneration', 'timeFrame': 'Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.', 'description': 'Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope'}], 'secondaryOutcomes': [{'measure': 'peroperative heparine/protaminesulphate ratio', 'timeFrame': 'The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours'}, {'measure': 'Platelet function', 'timeFrame': 'Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.', 'description': 'Platelet aggregation measured by Multiplate platelet function analyzer'}, {'measure': 'Thromboelastometry', 'timeFrame': 'Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.', 'description': 'We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness'}, {'measure': 'Standard coagulationtests', 'timeFrame': 'Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heparin treatment during cardiac surgery', 'Heparin reversal after cardiac surgery', 'Thrombin generation', 'Endogenous Thrombin potential'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find the heparinization method, which\n\n1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis\n2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.\n\nThe hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective on-pump coronary artery bypass grafting (CABG) single procedure\n* Elective aortavalve replacement (AVR) (single procedure)\n\nExclusion Criteria:\n\n* Emergency procedures\n* Children and youngsters less than 18 years\n* Pregnancy\n* Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)\n* Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)\n* Known coagulopathy\n* Endocarditis\n* Preoperative anaemia\n* Dialysis patients'}, 'identificationModule': {'nctId': 'NCT01462968', 'briefTitle': 'Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery', 'orgStudyIdInfo': {'id': 'N-20110037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Activated clotting time (ACT) group', 'description': 'heparinization measured as activated clotting time during surgery', 'interventionNames': ['Device: Activated clotting time versus blood-heparin concentration']}, {'type': 'EXPERIMENTAL', 'label': 'Hepcon group', 'description': 'heparinization measured as heparin concentration in the blood during surgery', 'interventionNames': ['Device: Activated clotting time versus blood-heparin concentration']}], 'interventions': [{'name': 'Activated clotting time versus blood-heparin concentration', 'type': 'DEVICE', 'otherNames': ['ACT', 'Hemochron Signature Elite', 'Hepcon', 'HMS'], 'description': 'Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration', 'armGroupLabels': ['Activated clotting time (ACT) group', 'Hepcon group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Susanne de Neergaard, Perfusionist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jan Jesper Andreasen, Professor, MD, PhD', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}