Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Arixtra (fondaparinux sodium); Intermittent compression devices (ICD)
Intervention description: Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.; All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 19 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Randomized Clinical Trials; Randomized Controlled Trial; Venous thrombosis; Anticoagulant Drugs; Doppler Ultrasound; Postoperative complications

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 Criteria:

          -  All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.

          -  Patients must be competent to self-administer injections, or must have caregivers or
             nurses who can perform injections

          -  Patients must have signed an approved informed consent

        Exclusion Criteria:

          -  Patients with medical history which requires chronic anticoagulation (i.e. previous
             DVT, 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 stasis
             ulcers)

          -  Patients receiving low molecular weight heparin or unfractionated heparin for
             prophylaxis post-operatively

          -  Patients who are unable to receive injections as an outpatient and/or unable to
             undergo 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.