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

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

MedlinePlus related topics:

Deep Vein Thrombosis

Drug Information available for:

Fondaparinux sodium ORG 31540

U.S. FDA Resources

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

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

Show 31 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Organon

More Information

Related Info This link exits the ClinicalTrials.gov site

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

Keywords provided by Sanofi-Aventis:

DVT Prevention

Major Abdominal Surgery

Venous Thromboembolic

Study placed in the following topic categories:

Embolism and Thrombosis

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 November 20, 2008

Sponsors and Collaborators:	Sanofi-Aventis Organon
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00038961