Study of Arixtra to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thrombosis
Intervention: Fondaparinux sodium (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s): Warner K. Huh, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham
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.
Clinical Details
Official title: Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
Secondary outcome: Incidence of Untoward Effects With Arixtra
Detailed description:
To assess the effectiveness of Arixtra in the prophylaxis of deep venous thromboembolism in
gynecologic oncology patients undergoing abdominopelvic surgery.
Eligibility
Minimum age: 19 Years.
Maximum age: 85 Years.
Gender(s): Female.
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.
Locations and Contacts
UAB, Women's and Infant Center, 1700 6th Avenue South, Birmingham, Alabama 35233, United States
Additional Information
Starting date: April 2007
Last updated: February 7, 2012
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