Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT03473132
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2018-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot study of consecutive patients.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio', 'timeFrame': 'through 48 hours', 'description': 'assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '30 days', 'description': 'bleeding'}, {'measure': 'adverse events', 'timeFrame': '30 days', 'description': 'thrombosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anticoagulation', 'Anticoagulation Reversal']}, 'descriptionModule': {'briefSummary': 'Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).', 'detailedDescription': 'Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LVAD on warfarin requiring temporary interruption of anticoagulation for procedures\n\nExclusion Criteria:\n\n* recent thrombotic event'}, 'identificationModule': {'nctId': 'NCT03473132', 'acronym': 'KVAD', 'briefTitle': 'Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC', 'orgStudyIdInfo': {'id': '2017P001254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Based on starting international normalized ratio (INR) and target INR, the dose of four factor prothrombin complex concentrate will be calculated and infused. Coagulation factor levels will be assessed over 48-72 hours.', 'interventionNames': ['Drug: four factor prothrombin complex concentrate']}], 'interventions': [{'name': 'four factor prothrombin complex concentrate', 'type': 'DRUG', 'description': 'After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Jolley, BA', 'role': 'CONTACT', 'email': 'kljolley@bwh.harvard.edu', 'phone': '617-525-9337'}, {'name': 'Revital Freedman, PhD', 'role': 'CONTACT', 'email': 'rfreedman5@bwh.harvard.edu', 'phone': '617-525-9337'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Jean M Connors, MD', 'role': 'CONTACT', 'email': 'jconnors@bwh.harvard.edu', 'phone': '617-525-9337'}, {'name': 'Revital Freedman, PhD', 'role': 'CONTACT', 'email': 'rfreedman5@bwh.harvard.edu', 'phone': '617-525-9337'}], 'overallOfficials': [{'name': 'Jean M Connors, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women';s Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'CSL Behring', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Hemostatic and Antithrombotic Stewardship Program', 'investigatorFullName': 'Jean M Connors', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}