Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT01101256
Status:
UNKNOWN
Last Update Posted:
2010-04-13
First Post:
2010-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of Residual Anticoagulatory Effects of Fondaparinux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Citrated blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'antiXa-levels (peak- and through-levels)', 'timeFrame': 'between day 3 and day 14 after start of therapy'}], 'secondaryOutcomes': [{'measure': 'thromboembolic or bleeding episodes, HIT', 'timeFrame': 'day 14 after start of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anticoagulant Prophylaxis/Therapy']}, 'referencesModule': {'references': [{'pmid': '14572200', 'type': 'BACKGROUND', 'citation': 'Paolucci F, Frasa H, Van Aarle F, Capdevla A, Clavies MC, van Dinther T, Donat F, Hendriks Y, van den Heuvel M, Nadal T, Lagrange F, Necciari J, Perez Y. Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices. Clin Lab. 2003;49(9-10):451-60.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with s.c. anticoagulant therapy (fondaparinux)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fondaparinux therapy for at least 3 days\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Hemodialysis'}, 'identificationModule': {'nctId': 'NCT01101256', 'briefTitle': 'Determination of Residual Anticoagulatory Effects of Fondaparinux', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux', 'orgStudyIdInfo': {'id': '66/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fondaparinux Prophylaxis group'}, {'label': 'Fondaparinux Therapy group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc Schindewolf, MD', 'role': 'CONTACT', 'email': 'marcschindewolf@yahoo.com', 'phone': '+49 (0)69-6301', 'phoneExt': '5096'}, {'name': 'Edelgard Lindhoff-Last, MD', 'role': 'CONTACT', 'email': 'lindhoff-last@em.uni-frankfurt.de', 'phone': '+49 (0)69-6301', 'phoneExt': '5096'}, {'name': 'Marc Schindewolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'J.W. Goethe University Hospital Frankfurt/M.', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Marc Schindewolf, MD', 'role': 'CONTACT', 'email': 'marcschindewolf@yahoo.com', 'phone': '+49 (0)69 6301', 'phoneExt': '5096'}], 'overallOfficials': [{'name': 'Marc Schindewolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'J.W. Goethe University Hospital Frankfurt/M.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Marc Schindewolf', 'oldOrganization': 'Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany'}}}}