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

Primary Purpose

Venous Thrombosis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Arixtra (fondaparinux sodium)
Intermittent compression devices (ICD)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thrombosis focused on measuring Randomized Clinical Trials, Randomized Controlled Trial, Venous thrombosis, Anticoagulant Drugs, Doppler Ultrasound, Postoperative complications

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • UAB, Women's and Infant Center, 1700 6th Avenue South

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intermittent compression devices (ICD)

Arixtra (fondaparinux sodium)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Secondary Outcome Measures

Incidence of Untoward Effects With Arixtra
Adverse events will be evaluated to determine untoward effects.

Full Information

First Posted
October 3, 2007
Last Updated
February 22, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00539942
Brief Title
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Problems with accrual
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis
Keywords
Randomized Clinical Trials, Randomized Controlled Trial, Venous thrombosis, Anticoagulant Drugs, Doppler Ultrasound, Postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent compression devices (ICD)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arixtra (fondaparinux sodium)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Arixtra (fondaparinux sodium)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intermittent compression devices (ICD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
Description
Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Incidence of Untoward Effects With Arixtra
Description
Adverse events will be evaluated to determine untoward effects.
Time Frame
21 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warner K. Huh, M.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB, Women's and Infant Center, 1700 6th Avenue South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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