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

Venous Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00539942
• Other study ID #: F070727009
• Secondary ID: UAB 0723
• Status: Terminated
• Phase: Phase 3
• First received: October 3, 2007
• Last updated: February 7, 2012
• Start date: April 2007
• Est. completion date: June 2010

Study information

• Verified date: February 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Fondaparinux sodium
Treatment will consist of daily injections of pharmacy prepared syringes of fondaparinux sodium 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.

Locations

Country	Name	City	State
United States	UAB, Women's and Infant Center, 1700 6th Avenue South	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of Untoward Effects With Arixtra	Adverse events will be evaluated to determine untoward effects.	21 days	Yes