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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT00510432
First received: August 1, 2007
Last updated: August 18, 2009
Last verified: August 2009
  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:


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

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Dermatology - Clinic of the Johann Wolfgang Goethe University
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Ralf J Ludwig, MD Department of Dermatology - Clinic of the Johann Wolfgang Goethe University
  More Information

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 
Study First Received: August 1, 2007
Last Updated: August 18, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on December 05, 2016