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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 3

Conditions: Venous Thrombosis

Treatments: Drug: Arixtra (fondaparinux sodium); Device: Intermittent compression devices (ICD)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00539942

F070727009

UAB 0723

Details and patient eligibility

About

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.

Full description

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

Enrollment: 7 patients

Sex: Female

Ages: 19 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Intermittent compression devices (ICD)

Active Comparator group

Description:

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.

Treatment:

Device: Intermittent compression devices (ICD)

Arixtra (fondaparinux sodium)

Experimental group

Description:

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).

Treatment:

Drug: Arixtra (fondaparinux sodium)