Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

October 24, 2019 updated by: Goetz Kloecker, University of Louisville

A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)

The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.

Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • high risk for HIT based on "Four Ts score" of 6 or more

Exclusion Criteria:

  • pulmonary emboli at the time of enrollment
  • arterial thrombosis at the time of enrollment
  • limb threatening phlegmasia cerulea dolens at the time of enrollment
  • Calculated Creatinin Clearance less than 50 ml/hr
  • platelet count less than 50
  • Weight less than 50 kg
  • pregnancy
  • allergy to fondaparinux
  • bacterial endocarditis
  • history of neuraxial anesthesia and post-operative indwelling epidural catheter
  • active major bleeding (hemodynamically significant or requiring transfusions)
  • inability to give informed consent

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2
Other Names:
  • Arixtra
Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks
Other Names:
  • Coumadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Showing Clinically Significant Bleeding
Time Frame: 4 weeks after INR reaches 2 or more
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
4 weeks after INR reaches 2 or more

Secondary Outcome Measures

Outcome Measure
Time Frame
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
Time Frame: 4 weeks after INR reaches 2 or more
4 weeks after INR reaches 2 or more

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Goetz H Kloecker, MD, MSPH, James Graham Brown Cancer Center

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

November 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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