AllergyNCT00510432
Incidence and Nature of Heparin-induced Skin Lesions in Medical Patients
An observational study of Allergy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving s.c. anti-coagulation
Who may be able to join
- age > 18 Y.
- s.c. anticoagulant therapy >6 days
Who cannot join
- history of HIT
- history of DTH to heparin
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Dermatology - Clinic of the Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, 60590
Ralf J Ludwig, MD, +49-69-6301- ext. 6162, r.ludwig@em.uni-frankfurt.de
Marc Schindewolf, MD, +49-69-6301- ext. 5444, marcschindewolf@yahoo.com
About this study
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.
- Conditions
- Allergy
- Keywords
- 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
- Medical subject headings
- Hypersensitivity, Hypersensitivity, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| s.c. anticoagulant therapy | All patients with s.c. anticoagulant therapy (UFH, LMWH, heparinoids, fondaparinux) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startApr 2007
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ralf J Ludwig, MD, Principal investigator, Department of Dermatology - Clinic of the Johann Wolfgang Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510432
- Sponsor's protocol ID
- 16/07
- Status last verified
- Aug 2009
- First submitted
- 1 Aug 2007
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17102645Ludwig 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.
PubMed 17080218Bircher 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.
PubMed 17073874Ludwig 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.
PubMed 16411404Warkentin 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.
PubMed 15888871Maetzke 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.
PubMed 15679737Gaigl 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.
PubMed 15667543Hirsch 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.
PubMed 15274739Koch 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.
PubMed 15025697Ludwig 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.
PubMed 14678213Warkentin 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.
PubMed 16857993Schindewolf 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.
PubMed 21741076Schindewolf 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.
PubMed 20843983Schindewolf 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.
PubMed 19786468
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inzidenz Und Art Heparin-induzierter Hautveränderungen
- ClinicalTrials.gov ID
- NCT00510432
- Acronym / sponsor ID
- 16/07
- Conditions
- Allergy
- Keywords
- heparin, heparin-induced thrombocytopenia, HIT, allergy, skin, dermatology, DTH, delayed-type hypersensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Jan 2009 (estimated)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| s.c. anticoagulant therapy | – | –All patients with s.c. anticoagulant therapy (UFH, LMWH, heparinoids, fondaparinux) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving s.c. anti-coagulation
Key inclusion criteria (2 listed)
- age > 18 Y.
- s.c. anticoagulant therapy >6 days
Key exclusion criteria (2 listed)
- history of HIT
- history of DTH to heparin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
- Background: PubMed 17102645Jappe 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.
- Background: PubMed 17080218Ludwig 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.
- Background: PubMed 17073874Bircher 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.
- Background: PubMed 16411404Ludwig 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.
- Background: PubMed 15888871Warkentin 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.
- Background: PubMed 15679737Maetzke 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.
- Background: PubMed 15667543Gaigl 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.
- Background: PubMed 15274739Hirsch 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.
- Background: PubMed 15025697Koch 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.
- Background: PubMed 14678213Ludwig 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.
- Background: PubMed 16857993Warkentin 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.
- Derived from this study: PubMed 21741076Schindewolf 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.
- Homepage of the Department of Internal Medicine (Angiology) with contact persons in the angiology department listed (site in German)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf J Ludwig, MD principal investigator
Department of Dermatology - Clinic of the Johann Wolfgang Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralf J Ludwig, MD (+49-69-6301- ext. 6162, r.ludwig@em.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510432, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009.