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Determination of Residual Anticoagulatory Effects of Fondaparinux

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ClinicalTrials.gov Identifier: NCT01101256
Recruitment Status : Unknown
Verified April 2010 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2010
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
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.

Condition or disease
Anticoagulant Prophylaxis/Therapy

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux
Study Start Date : April 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Fondaparinux Prophylaxis group
Fondaparinux Therapy group



Primary Outcome Measures :
  1. antiXa-levels (peak- and through-levels) [ Time Frame: between day 3 and day 14 after start of therapy ]

Secondary Outcome Measures :
  1. thromboembolic or bleeding episodes, HIT [ Time Frame: day 14 after start of therapy ]

Biospecimen Retention:   Samples With DNA
Citrated blood


Information from the National Library of Medicine

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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 with s.c. anticoagulant therapy (fondaparinux)
Criteria

Inclusion Criteria:

  • Fondaparinux therapy for at least 3 days

Exclusion Criteria:

  • Age < 18 years
  • Hemodialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101256


Contacts
Contact: Marc Schindewolf, MD +49 (0)69 6301 ext 5096 marcschindewolf@yahoo.com

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, MD    +49 (0)69-6301 ext 5096    lindhoff-last@em.uni-frankfurt.de   
Principal Investigator: Marc Schindewolf, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Marc Schindewolf, MD J.W. Goethe University Hospital Frankfurt/M.

Publications:
Responsible Party: Dr. Marc Schindewolf, Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany
ClinicalTrials.gov Identifier: NCT01101256     History of Changes
Other Study ID Numbers: 66/09
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents