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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


Phase 3
40 Years
N/A
Not Enrolling
Both
Venous Thrombosis, Surgery, Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism, Abdominal Surgery

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Trial Information

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

Inclusion 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

- Subject who had signed the informed consent.

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 surgical
closure.

- 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 ╬╝mol/L) in a well-hydrated subject,

- Documented hypersensitivity to contrast media,

- Use of any contraindicated drug that could not be combined with the injection of
contrast medium,

- Patent with evidence of leg ischemia caused by peripheral vascular disease, unable to
undergo 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 give
written 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 DVT
prophylaxis 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 to
concomitant 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 method
during the whole duration of study participation ,

- Subject with body weight <50 kg,

- Subjects, who in the opinion of the investigator, required a pharmacological
prophylaxis 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

venous thromboembolism (VTE

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

103414

NCT ID:

NCT00038961

Start Date:

October 2001

Completion Date:

October 2004

Related Keywords:

  • Venous Thrombosis
  • Surgery
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Venous Thromboembolism
  • Abdominal Surgery
  • DVT Prevention
  • Major Abdominal Surgery
  • Venous Thromboembolic
  • fondaparinux sodium
  • abdominal surgery
  • VTE prevention
  • venous thromboembolism
  • pulmonary embolism
  • Embolism
  • Pulmonary Embolism
  • Thromboembolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

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