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

NCT ID: NCT00539942

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-06-30

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.

Conditions

Venous Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intermittent compression devices (ICD)

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.

Group Type: ACTIVE_COMPARATOR

Intermittent compression devices (ICD)

Intervention Type: DEVICE

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.

Arixtra (fondaparinux sodium)

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).

Group Type: EXPERIMENTAL

Arixtra (fondaparinux sodium)

Intervention Type: DRUG

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.

Interventions

Arixtra (fondaparinux sodium)

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.

Intervention Type: DRUG

Intermittent compression devices (ICD)

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 Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Warner Huh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Warner K. Huh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB, Women's and Infant Center, 1700 6th Avenue South

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB 0723

Identifier Type: -

Identifier Source: secondary_id

F070727009

Identifier Type: -

Identifier Source: org_study_id