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
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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 |
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Allergy |
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 |

Group/Cohort |
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s.c. anticoagulant therapy
All patients with s.c. anticoagulant therapy (UFH, LMWH, heparinoids, fondaparinux)
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- age > 18 Y.
- s.c. anticoagulant therapy >6 days
Exclusion Criteria:
- history of HIT
- history of DTH to heparin

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
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 |
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 |
Principal Investigator: | Ralf J Ludwig, MD | Department of Dermatology - Clinic of the Johann Wolfgang Goethe University |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Calcium heparin Heparin Anticoagulants |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |