A Study to Evaluate the Efficacy and Safety of Fondaparinux Sodium When Used With Intermittent Pneumatic Compression to Prevent Venous Thromboembolic (IPC) Versus IPC Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal Surgery (APOLLO).

Last updated: August 31, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Thromboembolism

Treatment

N/A

Clinical Study ID

NCT00038961
103414
  • Ages > 40
  • All Genders

Study Summary

This is a multicentre, randomized, double-blind, placebo controlled study. During this study all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis with intermittent pneumatic compression (IPC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor)lasting longer than 45 minutes (duration from anesthesia induction to surgicalclosure)

  • Over 40 years of age

  • Subject who had signed the informed consent.

Exclusion

Exclusion Criteria:

  • Active, clinically significant bleeding

  • Documented congenital or acquired bleeding tendency/disorders

  • Active ulcerative gastrointestinal disease unless the reason for the present surgery.

  • Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation)brain, spinal, or ophthalmologic surgery.

  • Indwelling intrathecal or epidural catheters for more than 6 hours after surgicalclosure.

  • Subjects who had a traumatic puncture or unusual difficulty in applying the catheter

  • Known cerebral metastasis,

  • Subjects in whom hemostasis had not been established 6 hours after surgical closure,

  • Current thrombocytopenia,

  • Bacterial endocarditis

  • Creatinine level above 2.0 mg/dL (180 μmol/L) in a well-hydrated subject,

  • Documented hypersensitivity to contrast media,

  • Use of any contraindicated drug that could not be combined with the injection ofcontrast medium,

  • Patent with evidence of leg ischemia caused by peripheral vascular disease, unable toundergo IPC and unable to wear Elastic Stockings. Exclusion criteria related to trial methodology:

  • Mental disorders that could interfere with study participation and/or failure to givewritten informed consent to take part in the study,

  • Subject's life expectancy < 6 months,

  • Clinical sign of DVT and/or history of recent DVT,

  • Participation in any other therapeutic drug study or a device study evaluating DVTprophylaxis within 90 days preceding inclusion,

  • Previous participation in a study of fondaparinux sodium,

  • Known hypersensitivity to fondaparinux and its excipients,

  • Current addictive disorders that could interfere with study participation,

  • Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin,fibrinolytic agents or drugs blocking glycoprotein platelet receptors (GPIIb-IIIa)during the screening period, i.e., from admission to surgery,

  • Subjects for whom anticoagulant therapy was contraindicated or who had, due toconcomitant disease, an indication for oral anticoagulant or heparins (including LMWH)and who could not discontinue those treatments,

  • Women of child-bearing potential: women not using an appropriate contraceptive methodduring the whole duration of study participation ,

  • Subject with body weight <50 kg,

  • Subjects, who in the opinion of the investigator, required a pharmacologicalprophylaxis in addition to intermittent pneumatic compression,

  • Known pregnancy and / or women who intended to breastfeed,

  • Subjects undergoing vascular surgery such as aorto-femoral bypass graft

Study Design

Total Participants: 1309
Study Start date:
November 01, 2001
Estimated Completion Date:
October 31, 2004

Study Description

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of fondaparinux in the prevention of venous thromboembolism (VTE) in subjects undergoing abdominal surgery at increased risk for VTE. During this study all subjects were to receive background VTE prophylaxis with intermittent pnuematic compression (IPC) ± elastic stockings (ES).

Screening Period ( Day -30-Day 0) all subjects at increased risk of VTE undergoing abdominal surgery and fulfilled the study entry criteria were eligible for the study.

Treatment Period (Day 7 ±2): At the baseline assessment on the day of surgery (Day 1) subjects who satisfied all inclusion/exclusion criteria were randomized (1:1) to receive either fondaparinux or placebo. All the subjects were to receive background therapy with IPC ±ES. The first administration of either fondaparinux 2.5mg or placebo was to take place 6 to 8 hours after surgical closure provided hemostasis was achieved. Thereafter a once daily subcutaneous injection of either fondaparinux 2.5mg or placebo was to be administered up to Day 7 ±2. During the treatment phase, subjects were assessed daily. A mandatory venogram was performed between Day 5 and 10 or earlier in the case of symptomatic VTE, but not more than 1 calendar day after the last study treatment administration.

Follow up Period (Day 30 ±2): A follow-up visit or contact was to take place at Day 30 ±2 days. Use of antithrombotic therapy for prevention of VTE after the mandatory venographyand during the entire Follow-up Period was left to the investigator's discretion.

Connect with a study center

  • Princeton Baptist Medical Center

    Birmingham, Alabama 35211-1399
    United States

    Site Not Available

  • Scottsdale Urologic and Reproductive Specialists

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Saguaro Surgical

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Saddleback Medical Research Services

    San Diego, California 92122
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93102
    United States

    Site Not Available

  • Denver Health Medical Center

    Denver, Colorado 80204
    United States

    Site Not Available

  • PAB Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Baptist Regional Cancer Institute

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Surgical Associates of Central Florida, P.A.

    Orlando, Florida 32804
    United States

    Site Not Available

  • Sacred Heart Hospital

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Sheridan Clinical Research Group

    Sunrise, Florida 33323
    United States

    Site Not Available

  • MCCA

    Tampa, Florida 33612
    United States

    Site Not Available

  • Rehabilitation Institute of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • UIC College of Medicine @ Peoria - Dept. of Surgery

    Peoria, Illinois 61603
    United States

    Site Not Available

  • Consultants in Pulmonary Medicine

    Olathe, Kansas 66061
    United States

    Site Not Available

  • Susan Galandiuk

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Commonwealth Biomedical Research, LLC

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • VA Medical Center Hem/ONC Dept

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • University of Mississippi Medical Center - Division of Urology

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Truman Medical Center West - Dept of Surgery

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Leonard Galler

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • State University of New York

    Buffalo, New York 14203-1154
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • VA Medical Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • St. Joseph's Hospital - Dept. of Surgery

    Houston, Texas 77002
    United States

    Site Not Available

  • McGuire VAMC

    Richmond, Virginia 23249
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.