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Venous Thrombosis |
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Clinical Trial: Safety Study of Fondaparinux Sodium to Prevent Venous Thromboembolic Events (APOLLO)
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Venous Thrombosis | Drug: Fondaparinux Sodium | Phase III |
MedlinePlus related topics: Vascular Diseases
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
Expected Total Enrollment: 1070
Study start: October 2001; Study completion: July 2004
Eligibility
Ages Eligible for Study: 40 Years and above, Genders Eligible for Study: Both
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
Location Information
Alabama
Princeton Baptist Medical Center, Birmingham, Alabama, 35211-1399, United States
Arizona
Saguaro Surgical, Tucson, Arizona, 85712, United States
Scottsdale Urologic and Reproductive Specialists, Scottsdale, Arizona, 85258, United States
California
Santa Barbara Cottage Hospital, Santa Barbara, California, 93102, United States
Saddleback Medical Research Services, San Diego, California, 92122, United States
Colorado
Denver Health Medical Center, Denver, Colorado, 80204, United States
Florida
Baptist Regional Cancer Institute, Jacksonville, Florida, 32207, United States
Sacred Heart Hospital, Pensacola, Florida, 32503, United States
Surgical Associates of Central Florida, P.A., Orlando, Florida, 32804, United States
Sheridan Clinical Research Group, Sunrise, Florida, 33323, United States
PAB Clinical Research, Brandon, Florida, 33511, United States
MCCA, Tampa, Florida, 33612, United States
Illinois
UIC College of Medicine @ Peoria - Dept. of Surgery, Peoria, Illinois, 61603, United States
Rehabilitation Institute of Chicago, Chicago, Illinois, 60611, United States
Kansas
Consultants in Pulmonary Medicine, Olathe, Kansas, 66061, United States
Kentucky
Commonwealth Biomedical Research, LLC, Madisonville, Kentucky, 42431, United States
Susan Galandiuk, Louisville, Kentucky, 40202, United States
Massachusetts
Baystate Medical Center, Springfield, Massachusetts, 01199, United States
Minnesota
VA Medical Center Hem/ONC Dept, Minneapolis, Minnesota, 55417, United States
Mississippi
University of Mississippi Medical Center - Division of Urology, Jackson, Mississippi, 39216-4505, United States
Missouri
Truman Medical Center West - Dept of Surgery, Kansas City, Missouri, 64108, United States
Nevada
Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States
New Jersey
Leonard Galler, Somers Point, New Jersey, 08244, United States
New York
State University of New York, Buffalo, New York, 14203-1154, United States
Albany Medical Center, Albany, New York, 12208, United States
University of Rochester Medical Center, Rochester, New York, 14642, United States
Oklahoma
VA Medical Center, Oklahoma City, Oklahoma, 73104, United States
Pennsylvania
Lehigh Valley Hospital, Allentown, Pennsylvania, 18103, United States
The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States
Texas
St. Joseph's Hospital - Dept. of Surgery, Houston, Texas, 77002, United States
Virginia
McGuire VAMC, Richmond, Virginia, 23249, United States
More Information
http://sanofi-synthelabous.com
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: June 5, 2002
ClinicalTrials.gov Identifier: NCT00038961
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- What Is Deep Vein Thrombosis? (National Heart, Lung and Blood Institute)
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