Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02319460
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005164', 'term': 'Factor IX'}, {'id': 'C525441', 'term': 'factor IX, factor VII, factor X, prothrombin drug combination'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2238}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of thromboembolic events (TEE) for patients without a recent history of TEE', 'timeFrame': 'Within 45 days after the index date', 'description': 'The risk of confirmed thromboembolic events (TEE) will be estimated for patients without a recent history of TEE treated with Kcentra® compared to patients treated with plasma. The index date is the date of acute VKA reversal for major bleeding event.'}], 'secondaryOutcomes': [{'measure': 'Risk of thromboembolic events', 'timeFrame': 'Within 45 days after the index date', 'description': 'The risk of confirmed TEE and confirmed fatal TEE will be each estimated for patients treated with Kcentra® compared to patients treated with plasma, overall and for patients in the following subgroups:\n\n* Recent history of TEE\n* No recent history of TEE\n* Any history of TEE\n\nThe index date is the date of acute VKA reversal for major bleeding event.'}, {'measure': 'Risk of death from any cause', 'timeFrame': 'Within 45 days after the index date', 'description': 'The risk of death from any cause will be estimated for patients treated with Kcentra® compared to patients treated with plasma, overall and for patients in the following subgroups:\n\n* Recent history of TEE\n* No recent history of TEE\n* Any history of TEE\n\nThe index date is the date of acute VKA reversal for major bleeding event.'}, {'measure': 'Rates of use of VKA therapy after the index date', 'timeFrame': 'Within 90 days after the index date', 'description': 'The rates of use of VKA therapy or other antithrombotic agents will be assessed among patients with and without any history of TEE. The index date is the date of acute VKA reversal for major bleeding event.'}]}, 'conditionsModule': {'keywords': ['Vitamin K Reversal Antagonist Therapy of Acute Major Bleeding', 'Warfarin Reversal'], 'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations. In the setting of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated with plasma will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult members of the Kaiser Permanente Northern and Southern California health care delivery systems, receiving chronic warfarin therapy and meeting study eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and older at admission for VKA-associated major bleeding\n* A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment\n* A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment\n\nExclusion Criteria:\n\nPatients will be excluded from the primary analyses if they:\n\n* Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)\n* Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)'}, 'identificationModule': {'nctId': 'NCT02319460', 'briefTitle': 'An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'An Observational Cohort Study of the Risk of Thromboembolic Events Among Adult Patients Treated With KCENTRA® Compared With Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding', 'orgStudyIdInfo': {'id': 'BE1116_4001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective', 'description': 'Retrospective cohort of adults hospitalized for major bleeding during 2008 to 2013 who receive plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy', 'interventionNames': ['Biological: Plasma']}, {'label': 'Prospective', 'description': 'Prospective parallel cohort of adults hospitalized for major bleeding during 2014 to 2020 who either receive Kcentra® or plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy', 'interventionNames': ['Biological: Kcentra®', 'Biological: Plasma']}], 'interventions': [{'name': 'Kcentra®', 'type': 'BIOLOGICAL', 'otherNames': ['Prothrombin Complex Concentrate (Human)', 'Beriplex'], 'description': 'Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product that contains coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S as a lyophilized concentrate.', 'armGroupLabels': ['Prospective']}, {'name': 'Plasma', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Prospective', 'Retrospective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Clinical Epidemiologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}, {'name': 'Alan S. Go, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}, {'name': 'Kristi Reynolds, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}