Venous Thrombosis
Conditions
Keywords
Randomized Clinical Trials, Randomized Controlled Trial, Venous thrombosis, Anticoagulant Drugs, Doppler Ultrasound, Postoperative complications
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.
Interventions
DRUGArixtra (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.
DEVICEIntermittent 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.
Sponsors
GlaxoSmithKline
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra | 21 days | Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Untoward Effects With Arixtra | 21 days | Adverse events will be evaluated to determine untoward effects. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the UAB Gynecologic Oncology Practice from 4/2007 to 6/2010
Pre-assignment details
Difficulty with recruiting subjects to this trial (subjects were not interested in participating)
Participants by arm
| Arm | Count |
|---|---|
| Intermittent Compression Devices Patients will receive standard intermittent compression devices (ICD's) during 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. | 4 |
| Fondaparinux (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 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge) | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Fondaparinux (Arixtra) | Intermittent Compression Devices | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 7 | 52 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 3 / 4 | 1 / 3 |
Outcome results
Primary
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.
Time frame: 21 days
Population: Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intermittent Compression Devices | Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra | 4 participants |
| Arixtra (Fondaparinux Sodium) | Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra | 3 participants |
Comparison: Unable to analyze datap-value: <0.05Chi-squared
Secondary
Incidence of Untoward Effects With Arixtra
Adverse events will be evaluated to determine untoward effects.
Time frame: 21 days
Population: Unable to analyze data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intermittent Compression Devices | Incidence of Untoward Effects With Arixtra | 0 participants |
| Arixtra (Fondaparinux Sodium) | Incidence of Untoward Effects With Arixtra | 0 participants |