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

NCT00539942 | Terminated Phase 3 Results DMC

• 2 other identifiers: F070727009UAB 0723
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thrombosis

Keywords

Randomized Clinical Trials; Randomized Controlled Trial; Venous thrombosis; Anticoagulant Drugs; Doppler Ultrasound; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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.

  21 days

Secondary Outcomes (1)

• Incidence of Untoward Effects With Arixtra

  21 days

Study Arms (2)

Intermittent compression devices (ICD)

ACTIVE COMPARATOR

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)

Arixtra (fondaparinux sodium)

EXPERIMENTAL

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)

Interventions

Arixtra (fondaparinux sodium) DRUG

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.

Arixtra (fondaparinux sodium)

Intermittent compression devices (ICD) DEVICE

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.

Intermittent compression devices (ICD)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

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

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Postoperative Complications

Interventions

Fondaparinux; Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates; Equipment and Supplies

Limitations and Caveats

This trial was terminated early due to poor enrollment and recruitment and the very small number of subjects analyzed. As such, the data is uninterpretable.

Results Point of Contact

• Title: Warner K. Huh, MD
• Organization: University of Alabama at Birmingham

warner.huh@ccc.uab.edu

205-996-4662

Study Officials

• Warner K. Huh, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 5, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 27, 2017
• Results First Posted: March 9, 2012

Record last verified: 2017-02

Locations

US (1)