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

Sponsors and Collaborators:	University of Alabama at Birmingham GlaxoSmithKline
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00539942

Purpose

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.

Condition	Intervention	Phase
Venous Thrombosis	Drug: fondaparinux sodium	Phase III

MedlinePlus related topics: Cancer Deep Vein Thrombosis

Drug Information available for: Fondaparinux sodium ORG 31540

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Deep venous thromboembolism rates determined by lower extremity doppler ultrasound [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and feasibility of use of Arixtra [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Standard of care arm: all patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only.
2: Experimental Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days).	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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	19 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539942

Contacts

Contact: Warner K. Huh, M.D.	205-934-4986	whuh@uab.edu
Contact: Jacqueline S Vaughn, BSN	205-930-8650	jvaughn@uabmc.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Warner K. Huh, M.D.

Sponsors and Collaborators

University of Alabama at Birmingham

GlaxoSmithKline

Investigators

Principal Investigator:

Warner K. Huh, M.D.

University of Alabama at Birmingham

More Information

Responsible Party:	University of Alabama at Birmingham ( Warner K Huh, M.D. )
Study ID Numbers:	F070727009, UAB0723
Study First Received:	October 3, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00539942
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Randomized Clinical Trials
Randomized Controlled Trial
Venous thrombosis

Anticoagulant Drugs
Doppler Ultrasound
Postoperative complications

Study placed in the following topic categories:

Embolism and Thrombosis
Postoperative Complications
Embolism
Vascular Diseases

Fondaparinux
Venous Thrombosis
Org 31540
Thrombosis

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009