Determination of Residual Anticoagulatory Effects of Fondaparinux

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
Information provided by:
Johann Wolfgang Goethe University Hospitals Identifier:
First received: April 7, 2010
Last updated: April 12, 2010
Last verified: April 2010
The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.

Anticoagulant Prophylaxis/Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux

Resource links provided by NLM:

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

Primary Outcome Measures:
  • antiXa-levels (peak- and through-levels) [ Time Frame: between day 3 and day 14 after start of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • thromboembolic or bleeding episodes, HIT [ Time Frame: day 14 after start of therapy ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA
Citrated blood

Estimated Enrollment: 110
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)
Fondaparinux Prophylaxis group
Fondaparinux Therapy group


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 with s.c. anticoagulant therapy (fondaparinux)

Inclusion Criteria:

  • Fondaparinux therapy for at least 3 days

Exclusion Criteria:

  • Age < 18 years
  • Hemodialysis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01101256

Contact: Marc Schindewolf, MD +49 (0)69 6301 ext 5096

J.W. Goethe University Hospital Frankfurt/M. Recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact: Marc Schindewolf, MD    +49 (0)69-6301 ext 5096   
Contact: Edelgard Lindhoff-Last, MD    +49 (0)69-6301 ext 5096   
Principal Investigator: Marc Schindewolf, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Principal Investigator: Marc Schindewolf, MD J.W. Goethe University Hospital Frankfurt/M.
  More Information

Responsible Party: Dr. Marc Schindewolf, Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany Identifier: NCT01101256     History of Changes
Other Study ID Numbers: 66/09 
Study First Received: April 7, 2010
Last Updated: April 12, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on May 02, 2016