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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

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.
 
Recruiting
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
No
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
Germany
 
NCT01102790
243/09
No
Edelgard Lindhoff-Last, Professor, J.W.Goethe University Hospital, Department of Internal Medicine, Division of Vascular Medicine
Johann Wolfgang Goethe University Hospitals
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 Hospitals
April 2010

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