Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by:
Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT01102790
First received: April 7, 2010
Last updated: April 14, 2010
Last verified: April 2010

April 7, 2010
April 14, 2010
April 2010
September 2010   (final data collection date for primary outcome measure)
incidence of HIT-antibodies [ Time Frame: between day 5 and day 14 after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01102790 on ClinicalTrials.gov Archive Site
thromboembolic events [ Time Frame: up to 21 days after surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure
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])
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
serum citrated blood edta blood
Non-Probability Sample
Patients in a primary care clinic undergoing orthopedic surgery without heparin exposure
  • Heparin-Induced Thrombocytopenia
  • Thrombosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
October 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Major orthopedic surgery

Exclusion Criteria:

  • Heparin exposure
  • Infection
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01102790
243/09
No
Not Provided
Not Provided
Edelgard Lindhoff-Last, Professor, J.W.Goethe University Hospital, Department of Internal Medicine, Division of Vascular Medicine
Johann Wolfgang Goethe University Hospital
Not Provided
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.
Johann Wolfgang Goethe University Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP