Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01112202
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2010-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dabigatran on Coagulation parameters-an ex Vivo Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['direct thrombin inhibitors', 'Dabigatran', 'Coagulation parameters'], 'conditions': ['Effect of Dabigatran in Laboratory Coagulation Parameters']}, 'descriptionModule': {'briefSummary': 'Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin 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 Pradaxa® on different coagulation parameters.', 'detailedDescription': 'This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 y\n\nExclusion Criteria:\n\n* Hemorrhagic disorder\n* Liver disease\n* Anemia\n* Severe renal impairment'}, 'identificationModule': {'nctId': 'NCT01112202', 'briefTitle': 'Effect of Dabigatran on Coagulation parameters-an ex Vivo Study', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery', 'orgStudyIdInfo': {'id': 'Dabi2010'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe University Hospital', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Edelgard Lindhoff-Last', 'oldOrganization': 'Department of Vascular Medicine, University Hospital Frankfurt'}}}}