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

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ClinicalTrials.gov Identifier: NCT00539942
Recruitment Status : Terminated (Problems with accrual)
First Posted : October 5, 2007
Results First Posted : March 9, 2012
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Warner Huh, University of Alabama at Birmingham

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Venous Thrombosis Drug: Arixtra (fondaparinux sodium) Device: Intermittent compression devices (ICD) Phase 3

Detailed Description:
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 (Fondaparinux Sodium): A Randomized Controlled Trial
Study Start Date : April 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: 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 (fondaparinux sodium)
Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) 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: Arixtra (fondaparinux sodium)
Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra [ Time Frame: 21 days ]
    Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.


Secondary Outcome Measures :
  1. Incidence of Untoward Effects With Arixtra [ Time Frame: 21 days ]
    Adverse events will be evaluated to determine untoward effects.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539942


Locations
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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
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Principal Investigator: Warner K. Huh, M.D. University of Alabama at Birmingham
More Information
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Responsible Party: Warner Huh, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00539942    
Other Study ID Numbers: F070727009
UAB 0723
First Posted: October 5, 2007    Key Record Dates
Results First Posted: March 9, 2012
Last Update Posted: March 27, 2017
Last Verified: February 2017
Keywords provided by Warner Huh, University of Alabama at Birmingham:
Randomized Clinical Trials
Randomized Controlled Trial
Venous thrombosis
 Anticoagulant Drugs
Doppler Ultrasound
Postoperative complications
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
PENTA
Fondaparinux
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents