Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-24 @ 7:14 AM
Study NCT ID:
NCT00986635
Status:
COMPLETED
Last Update Posted:
2011-04-08
First Post:
2009-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2009-09-29', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Activated partial thromboplastin time', 'Thrombin clotting Time', 'Anti-Xa-activity', 'Factor X-activity', 'Factor XIII-activity', 'Antithrombin (based on factor II)', 'Antithrombin (based on factor X<9'], 'conditions': ['Differences in Laboratory Coagulation Parameters']}, 'referencesModule': {'references': [{'pmid': '23138190', 'type': 'DERIVED', 'citation': 'Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Ex vivo effects of low-dose rivaroxaban on specific coagulation assays and coagulation factor activities in patients under real life conditions. Thromb Haemost. 2013 Jan;109(1):127-36. doi: 10.1160/TH12-04-0228. Epub 2012 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Xarelto® on different coagulation parameters.', 'detailedDescription': 'To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated.\n\nPlasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day).\n\nSeveral techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients after hip or knee replacement surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d\n* must be able to accept blood sampling'}, 'identificationModule': {'nctId': 'NCT00986635', 'briefTitle': 'Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'orgStudyIdInfo': {'id': 'RIV139/09'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Helen Mani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital Frankfurt/Main Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Edelgard Lindhoff-Last, MD', 'oldOrganization': 'Vascular Medicine, Johann Wolfgang Goethe University Hospital Frankfurt/Main'}}}}