Clinical trial NCT00539942: Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
Official title: Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Venous Thrombosis
Keywords: Randomized Clinical Trials
Randomized Controlled Trial
Venous thrombosis
Anticoagulant Drugs
Doppler Ultrasound
Postoperative complications
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-10-05
Enrollment: 7
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

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.

Primary outcomes:
measure: Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
timeFrame: 21 days
Secondary outcomes:
measure: Incidence of Untoward Effects With Arixtra
timeFrame: 21 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB, Women's and Infant Center, 1700 6th Avenue South
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Warner K. Huh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: