NCT00510432

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

August 1, 2007

Last Update Submit

August 18, 2009

Conditions

Allergy

Keywords

heparinheparin-induced thrombocytopeniaHITallergyskindermatologyDTHdelayed-type hypersensitivityhistologyPatients receiving sc heparin therapyAge over 18 yearsRecruitment will stop when 20 patients with skin lesions are included

Study Arms (1)

s.c. anticoagulant therapy

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving s.c. anti-coagulation

You may qualify if:

  • age \> 18 Y.
  • s.c. anticoagulant therapy \>6 days

You may not qualify if:

  • history of HIT
  • history of DTH to heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology - Clinic of the Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Related Publications (14)

  • Jappe U. Allergy to heparins and anticoagulants with a similar pharmacological profile: an update. Blood Coagul Fibrinolysis. 2006 Nov;17(8):605-13. doi: 10.1097/01.mbc.0000198992.18384.5a.

    PMID: 17102645BACKGROUND

  • 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.

    PMID: 17080218BACKGROUND

  • Bircher AJ, Harr T, Hohenstein L, Tsakiris DA. Hypersensitivity reactions to anticoagulant drugs: diagnosis and management options. Allergy. 2006 Dec;61(12):1432-40. doi: 10.1111/j.1398-9995.2006.01227.x.

    PMID: 17073874BACKGROUND

  • 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. doi: 10.1160/TH05-05-0318.

    PMID: 16411404BACKGROUND

  • 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. doi: 10.1378/chest.127.5.1857.

    PMID: 15888871BACKGROUND

  • 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. doi: 10.1111/j.1398-9995.2005.00695.x. No abstract available.

    PMID: 15679737BACKGROUND

  • 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. doi: 10.1111/j.1365-2141.2004.05321.x.

    PMID: 15667543BACKGROUND

  • 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. doi: 10.1111/j.0105-1873.2004.0350j.x. No abstract available.

    PMID: 15274739BACKGROUND

  • 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. doi: 10.1111/j.0105-1873.2003.0255.x.

    PMID: 15025697BACKGROUND

  • 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. doi: 10.1111/j.0105-1873.2003.0185a.x. No abstract available.

    PMID: 14678213BACKGROUND

  • 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. doi: 10.1182/blood-2005-11-012450. Epub 2006 Jul 20.

    PMID: 16857993BACKGROUND

  • 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. doi: 10.1016/j.thromres.2011.06.008. Epub 2011 Jul 7.

    PMID: 21741076DERIVED

  • 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. doi: 10.4065/mcp.2010.0346. Epub 2010 Sep 15.

    PMID: 20843983DERIVED

  • 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. doi: 10.1503/cmaj.081729. Epub 2009 Sep 28.

    PMID: 19786468DERIVED

Related Links

MeSH Terms

Conditions

HypersensitivityHypersensitivity, Delayed

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Ralf J Ludwig, MD

    Department of Dermatology - Clinic of the Johann Wolfgang Goethe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf J Ludwig, MD

CONTACT

+49-69-6301-r.ludwig@em.uni-frankfurt.de

Wolf-Henning Boehncke, Professor

CONTACT

+49-69-6301-boehncke@em.uni-frankfurt.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

April 1, 2007

Study Completion

January 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

DE(1)