Allergy Clinical Trial
Official title:
Inzidenz Und Art Heparin-induzierter Hautveränderungen
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | January 2009 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - age > 18 Y. - s.c. anticoagulant therapy >6 days Exclusion Criteria: - history of HIT - history of DTH to heparin |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Dermatology - Clinic of the Johann Wolfgang Goethe University | Frankfurt am Main | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
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. — View Citation
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. — View Citation
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. — View Citation
Jappe U. Allergy to heparins and anticoagulants with a similar pharmacological profile: an update. Blood Coagul Fibrinolysis. 2006 Nov;17(8):605-13. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
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