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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
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01101256
First received: April 7, 2010
Last updated: April 12, 2010
Last verified: April 2010
History of Changes
  Purpose

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
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:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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)
Groups/Cohorts
Fondaparinux Prophylaxis group
Fondaparinux Therapy group

  Eligibility

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)

Criteria

Inclusion Criteria:

  • Fondaparinux therapy for at least 3 days

Exclusion Criteria:

  • Age < 18 years
  • Hemodialysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
Investigators
Principal Investigator: Marc Schindewolf, MD J.W. Goethe University Hospital Frankfurt/M.
  More Information

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
Study First Received: April 7, 2010
Last Updated: April 12, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013