Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2010 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT01102790

First received: April 7, 2010

Last updated: April 14, 2010

Last verified: April 2010

History of Changes

Purpose

The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.

Condition
Heparin-Induced Thrombocytopenia Thrombosis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Generation of HIT-antibodies Without Prior Heparin Exposure Following Orthopedic Surgery (Subgroup Study) (Change of Coagulation Parameters Under Exposition With New Anticoagulants [Title of the Main Study])

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

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

Primary Outcome Measures:

incidence of HIT-antibodies [ Time Frame: between day 5 and day 14 after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

thromboembolic events [ Time Frame: up to 21 days after surgery ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

serum citrated blood edta blood

Estimated Enrollment:	160
Study Start Date:	April 2010
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients in a primary care clinic undergoing orthopedic surgery without heparin exposure

Criteria

Inclusion Criteria:

Major orthopedic surgery

Exclusion Criteria:

Heparin exposure
Infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102790

Contacts

Contact: Marc Schindewolf, MD	+49 (0)69-6301 ext 5096	marcschindewolf@yahoo.com
Contact: Edelgard Lindhoff-Last, Prof.	+49 (0)69-6301 ext 5096	Lindhoff-Last@em.uni-frankfurt.de

Locations

Germany
J.W.Goethe University Hospital Frankfurt/M.	Recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact: Marc Schindewolf, MD +49 (0)69-6301 ext 5096 marcschindewolf@yahoo.com
Contact: Edelgard Lindhoff-Last, Prof. +49 (0)69-6301 ext 5096 Lindhoff-Last@em.uni-frankfurt.de
Principal Investigator: Edelgard Lindhoff-Last, Prof.
Principal Investigator: Marc Schindewolf, MD

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:	Marc Schindewolf, MD	J.W. Goethe University-Hospital Frankfurt/M.
Principal Investigator:	Edelgard Lindhoff-Last, Prof.	J.W. Goethe-University Hospital Frankfurt/M.

More Information

Publications:

Schindewolf M, Lindhoff-Last E. Fondaparinux-related thrombocytopenia in a patient with former HIT. Response to Rota et al. (Thromb Haemost 2008; 99: 779-781). Thromb Haemost. 2008 Jul;100(1):168-9; author reply 169-70. No abstract available.

Warkentin TE, Makris M, Jay RM, Kelton JG. A spontaneous prothrombotic disorder resembling heparin-induced thrombocytopenia. Am J Med. 2008 Jul;121(7):632-6.

Jay RM, Warkentin TE. Fatal heparin-induced thrombocytopenia (HIT) during warfarin thromboprophylaxis following orthopedic surgery: another example of 'spontaneous' HIT? J Thromb Haemost. 2008 Sep;6(9):1598-600. Epub 2008 May 29. No abstract available.

Responsible Party:	Edelgard Lindhoff-Last, Professor, J.W.Goethe University Hospital, Department of Internal Medicine, Division of Vascular Medicine
ClinicalTrials.gov Identifier:	NCT01102790 History of Changes
Other Study ID Numbers:	243/09
Study First Received:	April 7, 2010
Last Updated:	April 14, 2010
Health Authority:	Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:

HIT

Additional relevant MeSH terms:

Thrombocytopenia
Thrombosis
Blood Platelet Disorders
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013

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