Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT00329433
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2006-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060225', 'term': 'desirudin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'avidanm@wustl.edu', 'phone': '314-747-4155', 'title': 'Michael S. Avidan, MBBCh', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study size was small and a surrogate end point was the primary outcome. The study was not powered to show statistical differences in clinical outcomes. Many patients received both desirudin and heparin during the study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Desirudin', 'description': 'Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Heparin', 'description': 'Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desirudin', 'description': 'Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.'}, {'id': 'OG001', 'title': 'Heparin', 'description': 'Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of \\<0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days after surgery', 'description': 'Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis was performed according to initial group assignment.'}, {'type': 'SECONDARY', 'title': 'The Incidence of DVTs in Each Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desirudin', 'description': 'Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.'}, {'id': 'OG001', 'title': 'Heparin', 'description': 'Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '61 in Desirudin group and 59 in heparin group.'}, {'type': 'SECONDARY', 'title': 'The Incidence of Bleeding in Each Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desirudin', 'description': 'Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.'}, {'id': 'OG001', 'title': 'Heparin', 'description': 'Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Desirudin', 'description': 'Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.'}, {'id': 'FG001', 'title': 'Heparin', 'description': 'Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Desirudin', 'description': 'Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.'}, {'id': 'BG001', 'title': 'Heparin', 'description': 'Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).'}, {'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': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '11', 'groupId': 'BG000'}, {'value': '61', 'spread': '12', 'groupId': 'BG001'}, {'value': '61', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2006-05-22', 'resultsFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2006-05-22', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-11', 'studyFirstPostDateStruct': {'date': '2006-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.', 'timeFrame': '30 days after surgery', 'description': 'Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.'}], 'secondaryOutcomes': [{'measure': 'The Incidence of DVTs in Each Group.', 'timeFrame': '7 days after surgery'}, {'measure': 'The Incidence of Bleeding in Each Group.', 'timeFrame': 'Up to 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deep venous thrombosis', 'DVT', 'Heparin induced thrombocytopenia', 'HIT', 'Direct thrombin inhibitor'], 'conditions': ['Deep Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '21932952', 'type': 'DERIVED', 'citation': 'Graetz TJ, Tellor BR, Smith JR, Avidan MS. Desirudin: a review of the pharmacology and clinical application for the prevention of deep vein thrombosis. Expert Rev Cardiovasc Ther. 2011 Sep;9(9):1101-9. doi: 10.1586/erc.11.131.'}, {'pmid': '21794899', 'type': 'DERIVED', 'citation': 'Avidan MS, Smith JR, Skrupky LP, Hill L, Jacobsohn E, Burnside B, Tymkew H, Eby C, Damiano R, Despotis GJ. The occurrence of antibodies to heparin-platelet factor 4 in cardiac and thoracic surgical patients receiving desirudin or heparin for postoperative venous thrombosis prophylaxis. Thromb Res. 2011 Dec;128(6):524-9. doi: 10.1016/j.thromres.2011.05.025. Epub 2011 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled for elective Cardiac or Thoracic Surgery.\n* Age \\> 18 years of age.\n\nExclusion Criteria:\n\n* Patients with a clinical suspicion or a documented history of DVT/PE\n* Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)\n* Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.\n* Documented allergy to heparin, desirudin, or lepirudin\n* Patients with a history of coagulation disorder\n* Platelet count\\< 100 X109 /dl\n* Active bleeding\n* Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min\n* Patients with a baseline coagulopathy (INR \\> 1.5 or aPTT \\> 45 sec)\n* Patients with liver disease\n* Pregnancy\n* Patients who require ventricular assist devices before or after surgery'}, 'identificationModule': {'nctId': 'NCT00329433', 'briefTitle': 'Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients', 'orgStudyIdInfo': {'id': '05-0969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Heparin', 'description': 'Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).', 'interventionNames': ['Drug: Heparin']}, {'type': 'EXPERIMENTAL', 'label': 'Desirudin (Iprivask™)', 'description': 'Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.', 'interventionNames': ['Drug: Desirudin (Iprivask™)']}], 'interventions': [{'name': 'Desirudin (Iprivask™)', 'type': 'DRUG', 'description': 'Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.', 'armGroupLabels': ['Desirudin (Iprivask™)']}, {'name': 'Heparin', 'type': 'DRUG', 'description': 'The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).', 'armGroupLabels': ['Heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Michael S Avidan, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Charles Hantler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Bryan Meyers, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Barnes-Jewish Hospital', 'class': 'OTHER'}, {'name': 'Canyon Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Michael Avidan', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}