Try our beta test site

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
Information provided by:
Johann Wolfgang Goethe University Hospital Identifier:
First received: April 7, 2010
Last updated: April 14, 2010
Last verified: April 2010
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.

Heparin-Induced Thrombocytopenia

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)

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

Inclusion Criteria:

  • Major orthopedic surgery

Exclusion Criteria:

  • Heparin exposure
  • Infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01102790

J.W.Goethe University Hospital Frankfurt/M.
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
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

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

Keywords provided by Johann Wolfgang Goethe University Hospital:

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Immunologic Factors
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on February 17, 2017