Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT00245856
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2005-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Upper Extremity Deep-Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D056824', 'term': 'Upper Extremity Deep Vein Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017985', 'term': 'Dalteparin'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'suman-rathbun@ouhsc.edu', 'phone': '4052714742', 'title': 'Suman Rathbun MD', 'phoneExt': '44773', 'organization': 'University of Oklahoma Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dalteparin + Warfarin', 'description': '200 units per kg with transition Warfarin titrated to INR 2-3\n\nThis arm was completed and new treatment regimen was substituted for the remainder of the study.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dalteparin Only', 'description': '200 units/kg for one month At month one, dosage reduction based on weight', 'otherNumAtRisk': 39, 'otherNumAffected': 2, 'seriousNumAtRisk': 39, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants That Died at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All DVT Treated Patients', 'description': 'Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months'}], 'classes': [{'title': 'All cause mortality', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '17'}]}]}, {'title': 'Deaths attributed to DVT/PE', 'categories': [{'measurements': [{'value': '0', 'comment': 'This confidence interval was not calculated', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All DVT treated patients analyzed together'}, {'type': 'PRIMARY', 'title': 'New Venous Thromboembolism at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin + Warfarin or Dalteparin Alone', 'description': 'Patients with arm DVT who received either 3 months of dalteparin + warfarin (INR 2-3) or Dalteparin alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'New DVT or PE at 3 months confirmed by diagnostic testing', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All DVT treated patients analyzed together'}, {'type': 'SECONDARY', 'title': 'Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalteparin + Warfarin/Dalteparin Alone', 'description': 'Major bleeding rates'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Total major bleeding rate', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All DVT treated patients analyzed together'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dalteparin + Warfarin', 'description': '200 units per kg with transition Warfarin titrated to INR 2-3\n\nThis arm was completed and new treatment regimen was substituted for the remainder of the study.'}, {'id': 'FG001', 'title': 'Dalteparin Only', 'description': '200 units/kg for one month At month one, dosage reduction based on weight'}], 'periods': [{'title': 'Period One', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period Two', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment period November 2002 to December 2008 OUHSC hospital and clinics: OU Medical Center and VA Medical Center', 'preAssignmentDetails': 'Consecutive patients, both inpatient and outpatient, who had objectively confirmed upper extremity DVT found on standardized comprehensive duplex imaging or venogram. Ineligibility : predefined ineligibility criteria including high risk of bleeding.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All DVT Treated Patients', 'description': 'Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2005-10-26', 'resultsFirstSubmitDate': '2013-02-01', 'studyFirstSubmitQcDate': '2005-10-26', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-01', 'studyFirstPostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants That Died at 3 Months', 'timeFrame': '3 months'}, {'measure': 'New Venous Thromboembolism at 3 Months', 'timeFrame': '3 months', 'description': 'New DVT or PE at 3 months confirmed by diagnostic testing'}], 'secondaryOutcomes': [{'measure': 'Bleeding Events', 'timeFrame': '3 months', 'description': 'Total major bleeding rate'}]}, 'conditionsModule': {'keywords': ['Upper Extremity Deep-Vein Thrombosis', 'DVT', 'Fragmin', 'Deep-Vein Thrombosis', 'Thrombosis'], 'conditions': ['Deep-Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.', 'detailedDescription': 'Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.\n\nThe purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.\n\nAll patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.\n\nAll patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.\n\nAll patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram\n\nExclusion Criteria:\n\n* Active, clinically significant bleeding\n* Known hypersensitivity to heparin or low-molecular weight heparin\n* Currently pregnant or less than 1 week post-partum\n* Acquired bleeding diathesis\n* Known inherited bleeding disorder\n* Renal failure\n* Extremes of weight\n* Poor performance status\n* Unable to return for repeat diagnostic testing or follow-up visits'}, 'identificationModule': {'nctId': 'NCT00245856', 'briefTitle': 'Treatment of Upper Extremity Deep-Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Treatment of Upper Extremity Deep-Vein Thrombosis', 'orgStudyIdInfo': {'id': '10206'}, 'secondaryIdInfos': [{'id': 'ORA-20020622', 'type': 'OTHER', 'domain': 'University of Oklahoma Office of Research Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment of Upper Extremity DVT', 'description': 'Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT', 'interventionNames': ['Drug: Dalteparin sodium injection', 'Drug: Warfarin']}], 'interventions': [{'name': 'Dalteparin sodium injection', 'type': 'DRUG', 'otherNames': ['Fragmin'], 'description': '200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.', 'armGroupLabels': ['Treatment of Upper Extremity DVT']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Titrated to INR 2-3 through study month 3', 'armGroupLabels': ['Treatment of Upper Extremity DVT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Suman W. Rathbun, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Suman Rathbun', 'investigatorAffiliation': 'University of Oklahoma'}}}}