Study of Arixtra to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

This study has been terminated.
(Problems with accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Warner Huh, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00539942
First received: October 3, 2007
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.


Condition Intervention Phase
Venous Thrombosis
Drug: Fondaparinux sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.


Secondary Outcome Measures:
  • Incidence of Untoward Effects With Arixtra [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    Adverse events will be evaluated to determine untoward effects.


Enrollment: 7
Study Start Date: April 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Intermittent compression devices (ICD)
All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
Experimental: Arixtra
Patients randomized to treatment arm will initiate Arixtra treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).
Drug: Fondaparinux sodium
Treatment will consist of daily injections of pharmacy prepared syringes of fondaparinux sodium 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.
Other Name: Arixtra

Detailed Description:

To assess the effectiveness of Arixtra in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

  Eligibility

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.
  • Patients must be competent to self-administer injections, or must have caregivers or nurses who can perform injections
  • Patients must have signed an approved informed consent

Exclusion Criteria:

  • Patients with medical history which requires chronic anticoagulation (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
  • Patients with contraindications to anticoagulation (generalized bleeding disorders, peptic ulcer disease, hemorrhagic stroke, etc)
  • Contraindications to placement of ICDs (history of lower extremity venous stasis ulcers)
  • Patients receiving low molecular weight heparin or unfractionated heparin for prophylaxis post-operatively
  • Patients who are unable to receive injections as an outpatient and/or unable to undergo a doppler ultrasound of the lower extremities
  • Renal insufficiency (creatinine clearance < 30 mL/min)
  • Patients who have a body weight < 50 kg
  • Hypersensitivity to low molecular weight heparin
  • Patients who are pregnant or have a positive pregnancy test.
  • Patients receiving continuous (indwelling) epidural.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539942

Locations
United States, Alabama
UAB, Women's and Infant Center, 1700 6th Avenue South
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
GlaxoSmithKline
Investigators
Principal Investigator: Warner K. Huh, M.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Warner Huh, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00539942     History of Changes
Other Study ID Numbers: F070727009, UAB 0723
Study First Received: October 3, 2007
Results First Received: February 7, 2012
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Randomized Clinical Trials
Randomized Controlled Trial
Venous thrombosis
Anticoagulant Drugs
Doppler Ultrasound
Postoperative complications

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014