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

The recruitment status of this study is unknown because the information has not been verified recently.

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

Sponsor:

Information provided by:

Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT00510432

First received: August 1, 2007

Last updated: August 18, 2009

Last verified: August 2009

History of Changes

Purpose

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
Allergy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Inzidenz Und Art Heparin-induzierter Hautveränderungen

Resource links provided by NLM:

MedlinePlus related topics: Allergy Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Estimated Enrollment:	500
Study Start Date:	April 2007
Estimated Study Completion Date:	January 2009

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510432

Contacts

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

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 Hospitals

Investigators

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 Dermatology with contact persons in the dermatology department listed (site in German) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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

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. No abstract available.

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.

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. No abstract available.

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. No abstract available.

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.

Additional 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. 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. 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. Epub 2009 Sep 28.

Responsible Party:	Dr. Marc Schindewolf, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00510432 History of Changes
Other Study ID Numbers:	16/07
Study First Received:	August 1, 2007
Last Updated:	August 18, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:

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:

Hypersensitivity
Immune System Diseases
Anticoagulants
Heparin
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013

To Top