Incidence and Nature of Heparin-induced Skin Lesions in Medical Patients
Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00510432
Collaborator
(none)
500
1
21.1
23.7
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inzidenz Und Art Heparin-induzierter Hautveränderungen
Study Start Date
:
Apr 1, 2007
Anticipated Study Completion Date
:
Jan 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| s.c. anticoagulant therapy All patients with s.c. anticoagulant therapy (UFH, LMWH, heparinoids, fondaparinux) |
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
age > 18 Y.
-
s.c. anticoagulant therapy >6 days
Exclusion Criteria:
-
history of HIT
-
history of DTH to heparin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- Jappe U. Allergy to heparins and anticoagulants with a similar pharmacological profile: an update. Blood Coagul Fibrinolysis. 2006 Nov;17(8):605-13. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00510432
Other Study ID Numbers:
- 16/07
First Posted:
Aug 2, 2007
Last Update Posted:
Aug 19, 2009
Last Verified:
Aug 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: