Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-28 @ 11:48 PM
Study NCT ID:
NCT00510432
Status:
UNKNOWN
Last Update Posted:
2009-08-19
First Post:
2007-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Nature of Heparin-induced Skin Lesions in Medical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-18', 'studyFirstSubmitDate': '2007-08-01', 'studyFirstSubmitQcDate': '2007-08-01', 'lastUpdatePostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heparin', 'heparin-induced thrombocytopenia', 'HIT', 'allergy', 'skin', 'dermatology', 'DTH', 'delayed-type hypersensitivity', 'histology', 'Patients receiving sc heparin therapy', 'Age over 18 years', 'Recruitment will stop when 20 patients with skin lesions are included'], 'conditions': ['Allergy']}, 'referencesModule': {'references': [{'pmid': '17102645', 'type': 'BACKGROUND', 'citation': 'Jappe U. Allergy to heparins and anticoagulants with a similar pharmacological profile: an update. Blood Coagul Fibrinolysis. 2006 Nov;17(8):605-13. doi: 10.1097/01.mbc.0000198992.18384.5a.'}, {'pmid': '17080218', 'type': 'BACKGROUND', 'citation': 'Ludwig RJ, Schindewolf M, Utikal J, Lindhoff-Last E, Boehncke WH. Management of cutaneous type IV hypersensitivity reactions induced by heparin. Thromb Haemost. 2006 Nov;96(5):611-7.'}, {'pmid': '17073874', 'type': 'BACKGROUND', 'citation': 'Bircher AJ, Harr T, Hohenstein L, Tsakiris DA. Hypersensitivity reactions to anticoagulant drugs: diagnosis and management options. Allergy. 2006 Dec;61(12):1432-40. doi: 10.1111/j.1398-9995.2006.01227.x.'}, {'pmid': '16411404', 'type': 'BACKGROUND', 'citation': 'Ludwig RJ, Schindewolf M, Alban S, Kaufmann R, Lindhoff-Last E, Boehncke WH. Molecular weight determines the frequency of delayed type hypersensitivity reactions to heparin and synthetic oligosaccharides. Thromb Haemost. 2005 Dec;94(6):1265-9. doi: 10.1160/TH05-05-0318.'}, {'pmid': '15888871', 'type': 'BACKGROUND', 'citation': 'Warkentin TE, Roberts RS, Hirsh J, Kelton JG. Heparin-induced skin lesions and other unusual sequelae of the heparin-induced thrombocytopenia syndrome: a nested cohort study. Chest. 2005 May;127(5):1857-61. doi: 10.1378/chest.127.5.1857.'}, {'pmid': '15679737', 'type': 'BACKGROUND', 'citation': 'Maetzke J, Hinrichs R, Schneider LA, Scharffetter-Kochanek K. Unexpected delayed-type hypersensitivity skin reactions to the ultra-low-molecular-weight heparin fondaparinux. Allergy. 2005 Mar;60(3):413-5. doi: 10.1111/j.1398-9995.2005.00695.x. No abstract available.'}, {'pmid': '15667543', 'type': 'BACKGROUND', 'citation': 'Gaigl Z, Pfeuffer P, Raith P, Brocker EB, Trautmann A. Tolerance to intravenous heparin in patients with delayed-type hypersensitivity to heparins: a prospective study. Br J Haematol. 2005 Feb;128(3):389-92. doi: 10.1111/j.1365-2141.2004.05321.x.'}, {'pmid': '15274739', 'type': 'BACKGROUND', 'citation': 'Hirsch K, Ludwig RJ, Lindhoff-Last E, Kaufmann R, Boehncke WH. Intolerance of fondaparinux in a patient allergic to heparins. Contact Dermatitis. 2004 Jun;50(6):383-4. doi: 10.1111/j.0105-1873.2004.0350j.x. No abstract available.'}, {'pmid': '15025697', 'type': 'BACKGROUND', 'citation': 'Koch P. Delayed-type hypersensitivity skin reactions due to heparins and heparinoids. Tolerance of recombinant hirudins and of the new synthetic anticoagulant fondaparinux. Contact Dermatitis. 2003 Dec;49(6):276-80. doi: 10.1111/j.0105-1873.2003.0255.x.'}, {'pmid': '14678213', 'type': 'BACKGROUND', 'citation': 'Ludwig RJ, Beier C, Lindhoff-Last E, Kaufmann R, Boehncke WH. Tolerance of fondaparinux in a patient allergic to heparins and other glycosaminoglycans. Contact Dermatitis. 2003 Sep;49(3):158-9. doi: 10.1111/j.0105-1873.2003.0185a.x. No abstract available.'}, {'pmid': '16857993', 'type': 'BACKGROUND', 'citation': 'Warkentin TE, Sheppard JA, Sigouin CS, Kohlmann T, Eichler P, Greinacher A. Gender imbalance and risk factor interactions in heparin-induced thrombocytopenia. Blood. 2006 Nov 1;108(9):2937-41. doi: 10.1182/blood-2005-11-012450. Epub 2006 Jul 20.'}, {'pmid': '21741076', 'type': 'DERIVED', 'citation': 'Schindewolf M, Scheuermann J, Kroll H, Marzi I, Kaufmann R, Boehncke WH, Ludwig RJ, Lindhoff-Last E. Application, tolerance and safety of fondaparinux therapy in a German hospital: a prospective single-centre experience. Thromb Res. 2012 Jan;129(1):17-21. doi: 10.1016/j.thromres.2011.06.008. Epub 2011 Jul 7.'}, {'pmid': '20843983', 'type': 'DERIVED', 'citation': 'Schindewolf M, Scheuermann J, Kroll H, Garbaraviciene J, Hecking C, Marzi I, Wolter M, Kaufmann R, Boehncke WH, Lindhoff-Last E, Ludwig RJ. Low allergenic potential with fondaparinux: results of a prospective investigation. Mayo Clin Proc. 2010 Oct;85(10):913-9. doi: 10.4065/mcp.2010.0346. Epub 2010 Sep 15.'}, {'pmid': '19786468', 'type': 'DERIVED', 'citation': 'Schindewolf M, Schwaner S, Wolter M, Kroll H, Recke A, Kaufmann R, Boehncke WH, Lindhoff-Last E, Ludwig RJ. Incidence and causes of heparin-induced skin lesions. CMAJ. 2009 Oct 13;181(8):477-81. doi: 10.1503/cmaj.081729. Epub 2009 Sep 28.'}], 'seeAlsoLinks': [{'url': 'http://www.gefaesszentrum-frankfurt.de', 'label': 'Homepage of the Department of Internal Medicine (Angiology) with contact persons in the angiology department listed (site in German)'}]}, 'descriptionModule': {'briefSummary': 'An increased number of patients with heparin-induced skin lesions is reported in the literature. Heparin-induced skin lesions may result from either occlusion of cutaneous vessels in patients suffering from autoimmune HIT or from a type IV allergic reaction (delayed type hypersensitivity (DTH) response). However, the incidence and nature of heparin-induced skin lesions has not been determined in a prospective investigation.\n\nTo address this open issue is the goal of this ongoing, so far monocenter, clinical investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving s.c. anti-coagulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 Y.\n* s.c. anticoagulant therapy \\>6 days\n\nExclusion Criteria:\n\n* history of HIT\n* history of DTH to heparin'}, 'identificationModule': {'nctId': 'NCT00510432', 'briefTitle': 'Incidence and Nature of Heparin-induced Skin Lesions in Medical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Inzidenz Und Art Heparin-induzierter Hautveränderungen', 'orgStudyIdInfo': {'id': '16/07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 's.c. anticoagulant therapy', 'description': 'All patients with s.c. anticoagulant therapy (UFH, LMWH, heparinoids, fondaparinux)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralf J Ludwig, MD', 'role': 'CONTACT', 'email': 'r.ludwig@em.uni-frankfurt.de', 'phone': '+49-69-6301-', 'phoneExt': '6162'}, {'name': 'Marc Schindewolf, MD', 'role': 'CONTACT', 'email': 'marcschindewolf@yahoo.com', 'phone': '+49-69-6301-', 'phoneExt': '5444'}, {'name': 'Ralf J Ludwig, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marc Schindewolf, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Svantje Schwaner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Edelgard Lindhoff-Last, PD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wolf-Henning Boehncke, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Dermatology - Clinic of the Johann Wolfgang Goethe University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Ralf J Ludwig, MD', 'role': 'CONTACT', 'email': 'r.ludwig@em.uni-frankfurt.de', 'phone': '+49-69-6301-', 'phoneExt': '6162'}, {'name': 'Wolf-Henning Boehncke, Professor', 'role': 'CONTACT', 'email': 'boehncke@em.uni-frankfurt.de', 'phone': '+49-69-6301-', 'phoneExt': '5143'}], 'overallOfficials': [{'name': 'Ralf J Ludwig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology - Clinic of the Johann Wolfgang Goethe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Marc Schindewolf', 'oldOrganization': 'Johann Wolfgang Goethe University Hospitals'}}}}