Determination of Residual Anticoagulatory Effects of Fondaparinux

April 12, 2010 updated by: Johann Wolfgang Goethe University Hospital

Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Recruiting
        • J.W. Goethe University Hospital Frankfurt/M.
        • Contact:
        • Principal Investigator:
          • Marc Schindewolf, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with s.c. anticoagulant therapy (fondaparinux)

Description

Inclusion Criteria:

  • Fondaparinux therapy for at least 3 days

Exclusion Criteria:

  • Age < 18 years
  • Hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Fondaparinux Prophylaxis group
Fondaparinux Therapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
antiXa-levels (peak- and through-levels)
Time Frame: between day 3 and day 14 after start of therapy
between day 3 and day 14 after start of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
thromboembolic or bleeding episodes, HIT
Time Frame: day 14 after start of therapy
day 14 after start of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Marc Schindewolf, MD, J.W. Goethe University Hospital Frankfurt/M.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 66/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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