Safety Study of Fondaparinux Sodium to Prevent Venous Thromboembolic Events (APOLLO) - Full Text View

Sponsor:	Sanofi-Aventis
Collaborator:	Organon
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00038961

Purpose

This study is a randomized, double-blind, deep vein thrombosis (DVT) prevention trial in patients undergoing major abdominal surgery in 80 U.S. centers. All patients receive background treatment of intermittent pneumatic compression devices. All subjects are assessed for DVTs with bilateral venography at the end of the study drug treatment period (day 5-9).

Condition	Intervention	Phase
Venous Thrombosis	Drug: Fondaparinux Sodium	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression Versus Intermittent Pneumatic Compression Used Alone for the Prevention of Venous Thromboembolic Events in Patients at Increased Risk Undergoing Major Abdominal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Surgery

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:	1070
Study Start Date:	October 2001
Estimated Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
Over 40 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038961

Hide Study Locations

Locations

United States, Alabama
Princeton Baptist Medical Center
Birmingham, Alabama, United States, 35211-1399
United States, Arizona
Saguaro Surgical
Tucson, Arizona, United States, 85712
Scottsdale Urologic and Reproductive Specialists
Scottsdale, Arizona, United States, 85258
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
Saddleback Medical Research Services
San Diego, California, United States, 92122
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Florida
Baptist Regional Cancer Institute
Jacksonville, Florida, United States, 32207
Sacred Heart Hospital
Pensacola, Florida, United States, 32503
Surgical Associates of Central Florida, P.A.
Orlando, Florida, United States, 32804
Sheridan Clinical Research Group
Sunrise, Florida, United States, 33323
PAB Clinical Research
Brandon, Florida, United States, 33511
MCCA
Tampa, Florida, United States, 33612
United States, Illinois
UIC College of Medicine @ Peoria - Dept. of Surgery
Peoria, Illinois, United States, 61603
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Kansas
Consultants in Pulmonary Medicine
Olathe, Kansas, United States, 66061
United States, Kentucky
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
Susan Galandiuk
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Minnesota
VA Medical Center Hem/ONC Dept
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
University of Mississippi Medical Center - Division of Urology
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Truman Medical Center West - Dept of Surgery
Kansas City, Missouri, United States, 64108
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Leonard Galler
Somers Point, New Jersey, United States, 08244
United States, New York
State University of New York
Buffalo, New York, United States, 14203-1154
Albany Medical Center
Albany, New York, United States, 12208
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Oklahoma
VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
St. Joseph's Hospital - Dept. of Surgery
Houston, Texas, United States, 77002
United States, Virginia
McGuire VAMC
Richmond, Virginia, United States, 23249

Sponsors and Collaborators

Sanofi-Aventis

Organon

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC3558, SR90107A, ARIXTRA, ORG31540
Study First Received:	June 5, 2002
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00038961 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

DVT Prevention
Major Abdominal Surgery
Venous Thromboembolic

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fondaparinux
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis

Org 31540
Pharmacologic Actions
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2009