DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thrombosis

Intervention: Fondaparinux sodium (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Warner K. Huh, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham

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.

Clinical Details

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

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

Primary outcome: Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra

Secondary outcome: Incidence of Untoward Effects With Arixtra

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

Eligibility

Minimum age: 19 Years. Maximum age: 85 Years. Gender(s): Female.

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.

Locations and Contacts

UAB, Women's and Infant Center, 1700 6th Avenue South, Birmingham, Alabama 35233, United States
Additional Information

Starting date: April 2007
Last updated: February 7, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017