Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

Last updated: February 22, 2017
Sponsor: University of Alabama at Birmingham
Overall Status: Terminated

Phase

3

Condition

Thrombosis

Venous Thromboembolism

Claudication

Treatment

N/A

Clinical Study ID

NCT00539942
F070727009
UAB 0723
  • Ages 19-85
  • Female
  • Accepts Healthy Volunteers

Study Summary

This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.

  • Patients must be competent to self-administer injections, or must have caregivers ornurses who can perform injections

  • Patients must have signed an approved informed consent

Exclusion

Exclusion Criteria:

  • Patients with medical history which requires chronic anticoagulation (i.e. previousDVT, pulmonary embolism, atrial fibrillation, heart valve replacement)

  • Patients with contraindications to anticoagulation (generalized bleeding disorders,peptic ulcer disease, hemorrhagic stroke, etc)

  • Contraindications to placement of ICDs (history of lower extremity venous stasisulcers)

  • Patients receiving low molecular weight heparin or unfractionated heparin forprophylaxis post-operatively

  • Patients who are unable to receive injections as an outpatient and/or unable toundergo a doppler ultrasound of the lower extremities

  • Renal insufficiency (creatinine clearance < 30 mL/min)

  • Patients who have a body weight < 50 kg

  • Hypersensitivity to low molecular weight heparin

  • Patients who are pregnant or have a positive pregnancy test.

  • Patients receiving continuous (indwelling) epidural.

Study Design

Total Participants: 7
Study Start date:
April 01, 2007
Estimated Completion Date:
June 30, 2010

Study Description

To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Connect with a study center

  • UAB, Women's and Infant Center, 1700 6th Avenue South

    Birmingham, Alabama 35233
    United States

    Site Not Available

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