Clinical Trial: Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial

Brief Summary:

RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer.

PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.

Secondary

  • Evaluate the safety of this regimen in these patients (4 weeks).
  • Determine the feasibility of this regimen in these patients (4 weeks).

OUTLINE: This is an open-label study.

Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo duplex ultrasonography of the lower extremities between day 28-35.


Sponsor: Masonic Cancer Center, University of Minnesota

Current Primary Outcome: Number of Patients With Venous Thromboembolism at Week 4 [ Time Frame: Week 4 (Days 28-35) ]

Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.


Original Primary Outcome:

Current Secondary Outcome: Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. [ Time Frame: Week 4 ]

This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.


Original Secondary Outcome:

Information By: Masonic Cancer Center, University of Minnesota

Dates:
Date Received: September 26, 2006
Date Started: January 2007
Date Completion:
Last Updated: November 6, 2012
Last Verified: November 2012