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

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

Official Title
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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

Conditions
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Venous Thrombosis

Intervention / Treatment
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* Drug: Arixtra (fondaparinux sodium)
* Device: Intermittent compression devices (ICD)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intermittent compression devices (ICD)<br>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. | Device: Intermittent compression devices (ICD)<br>* 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.<br>|
| Experimental: Arixtra (fondaparinux sodium)<br>Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge). | Drug: Arixtra (fondaparinux sodium)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra | Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Untoward Effects With Arixtra | Adverse events will be evaluated to determine untoward effects. | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Clinical Trials, Randomized Controlled Trial, Venous thrombosis, Anticoagulant Drugs, Doppler Ultrasound, Postoperative complications