Incidence and Nature of Heparin-induced Skin Lesions in Medical Patients

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ClinicalTrials.gov Identifier: NCT00510432

Recruitment Status : Unknown

Verified August 2009 by Johann Wolfgang Goethe University Hospital.
Recruitment status was: Recruiting

First Posted : August 2, 2007

Last Update Posted : August 19, 2009

Sponsor:

Information provided by:

Johann Wolfgang Goethe University Hospital

Study Description

Brief Summary:

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.

To address this open issue is the goal of this ongoing, so far monocenter, clinical investigation.

Condition or disease
Allergy

Study Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Inzidenz Und Art Heparin-induzierter Hautveränderungen
Study Start Date :	April 2007
Estimated Study Completion Date :	January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin Heparin sodium

Genetic and Rare Diseases Information Center resources: Heparin-induced Thrombocytopenia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
s.c. anticoagulant therapy All patients with s.c. anticoagulant therapy (UFH, LMWH, heparinoids, fondaparinux)

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients receiving s.c. anti-coagulation

Criteria

Inclusion Criteria:

age > 18 Y.
s.c. anticoagulant therapy >6 days

Exclusion Criteria:

history of HIT
history of DTH to heparin

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510432

Contacts

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Contact: Ralf J Ludwig, MD	+49-69-6301- ext 6162	r.ludwig@em.uni-frankfurt.de
Contact: Wolf-Henning Boehncke, Professor	+49-69-6301- ext 5143	boehncke@em.uni-frankfurt.de

Locations

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Germany
Department of Dermatology - Clinic of the Johann Wolfgang Goethe University	Recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact: Ralf J Ludwig, MD +49-69-6301- ext 6162 r.ludwig@em.uni-frankfurt.de
Contact: Marc Schindewolf, MD +49-69-6301- ext 5444 marcschindewolf@yahoo.com
Principal Investigator: Ralf J Ludwig, MD
Sub-Investigator: Marc Schindewolf, MD
Sub-Investigator: Svantje Schwaner, MD
Sub-Investigator: Edelgard Lindhoff-Last, PD
Sub-Investigator: Wolf-Henning Boehncke, Prof

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospital

Investigators

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Principal Investigator:	Ralf J Ludwig, MD	Department of Dermatology - Clinic of the Johann Wolfgang Goethe University

More Information

Additional Information:

Homepage of the Department of Internal Medicine (Angiology) with contact persons in the angiology department listed (site in German) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Jappe U. Allergy to heparins and anticoagulants with a similar pharmacological profile: an update. Blood Coagul Fibrinolysis. 2006 Nov;17(8):605-13. Review.

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. Review.

Bircher AJ, Harr T, Hohenstein L, Tsakiris DA. Hypersensitivity reactions to anticoagulant drugs: diagnosis and management options. Allergy. 2006 Dec;61(12):1432-40. Review.

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.

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.

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.

Gaigl Z, Pfeuffer P, Raith P, Bröcker 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.

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.

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.

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.

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. Epub 2006 Jul 20.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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Responsible Party:	Dr. Marc Schindewolf, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00510432 History of Changes
Other Study ID Numbers:	16/07
First Posted:	August 2, 2007 Key Record Dates
Last Update Posted:	August 19, 2009
Last Verified:	August 2009

Keywords provided by Johann Wolfgang Goethe University Hospital:


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

Additional relevant MeSH terms:

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Heparin Calcium heparin Anticoagulants	Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

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