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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102790
First Posted: April 13, 2010
Last Update Posted: April 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  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:


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

Primary Outcome Measures:
  • incidence of HIT-antibodies [ Time Frame: between day 5 and day 14 after surgery ]

Secondary Outcome Measures:
  • thromboembolic events [ Time Frame: up to 21 days after surgery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital
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:
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
First Submitted: April 7, 2010
First Posted: April 13, 2010
Last Update Posted: April 15, 2010
Last Verified: April 2010

Keywords provided by Johann Wolfgang Goethe University Hospital:
HIT

Additional relevant MeSH terms:
Thrombosis
Thrombocytopenia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Antibodies
Heparin
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action