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
- 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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
venous thromboembolism (VTE
the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE
adjudicated mandatory venogram positive for DVT between day 5 and day 10; up to day 10 for symptomatic DVT and/or adjudicated non fatal Pe , adjudicated fatal PE
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
103414
NCT00038961
October 2001
October 2004
Name | Location |
---|---|
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
University of Rochester Medical Center | Rochester, New York 14642 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Santa Barbara Cottage Hospital | Santa Barbara, California 93102 |
Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
Denver Health Medical Center | Denver, Colorado 80204-4507 |
Princeton Baptist Medical Center | Birmingham, Alabama 35211-1399 |
Scottsdale Urologic and Reproductive Specialists | Scottsdale, Arizona 85258 |
Saguaro Surgical | Tucson, Arizona 85712 |
Saddleback Medical Research Services | San Diego, California 92122 |
PAB Clinical Research | Brandon, Florida 33511 |
Baptist Regional Cancer Institute | Jacksonville, Florida 32207 |
Surgical Associates of Central Florida, P.A. | Orlando, Florida 32804 |
Sacred Heart Hospital | Pensacola, Florida 32503 |
Sheridan Clinical Research Group | Sunrise, Florida 33323 |
MCCA | Tampa, Florida 33612 |
Rehabilitation Institute of Chicago | Chicago, Illinois 60611 |
UIC College of Medicine @ Peoria - Dept. of Surgery | Peoria, Illinois 61603 |
Consultants in Pulmonary Medicine | Olathe, Kansas 66061 |
Susan Galandiuk | Louisville, Kentucky 40202 |
Commonwealth Biomedical Research, LLC | Madisonville, Kentucky 42431 |
VA Medical Center Hem/ONC Dept | Minneapolis, Minnesota 55417 |
University of Mississippi Medical Center - Division of Urology | Jackson, Mississippi 39216-4505 |
Truman Medical Center West - Dept of Surgery | Kansas City, Missouri 64108 |
Leonard Galler | Somers Point, New Jersey 08244 |
Albany Medical Center | Albany, New York 12208 |
State University of New York | Buffalo, New York 14203-1154 |
VA Medical Center | Oklahoma City, Oklahoma 73104 |
The Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
St. Joseph's Hospital - Dept. of Surgery | Houston, Texas 77002 |
McGuire VAMC | Richmond, Virginia 23249 |