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
  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 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:
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 April 22, 2014