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| ID | Type | Description | Link |
|---|---|---|---|
| UAB 0723 |
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Problems with accrual
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Untoward Effects With Arixtra | Adverse events will be evaluated to determine untoward effects. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warner K. Huh, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB, Women's and Infant Center, 1700 6th Avenue South | Birmingham | Alabama | 35233 | United States |
Difficulty with recruiting subjects to this trial (subjects were not interested in participating)
Patients were recruited from the UAB Gynecologic Oncology Practice from 4/2007 to 6/2010
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
|
| FG001 |
| Arixtra (Fondaparinux Sodium) |
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) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled. | Posted | Number | participants | 21 days |
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| Secondary | Incidence of Untoward Effects With Arixtra | Adverse events will be evaluated to determine untoward effects. | Unable to analyze data. | Posted | Number | participants | 21 days |
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21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 4 | 3 | 4 | 0 | 4 |
| EG001 | Arixtra (Fondaparinux Sodium) | 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) | 0 | 3 | 1 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic Abscess | Reproductive system and breast disorders | Non-systematic Assessment | subject developed a pelvic abscess following a hysterectomy for leiomyomas |
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| Postoperative Ileus | Gastrointestinal disorders | Non-systematic Assessment | subject developed a post-operative ileus following her surgery |
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| Postoperative Death | Surgical and medical procedures | Non-systematic Assessment | subject expired at an outside hospital approximately month following surgery |
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| Wound infection | Infections and infestations | Non-systematic Assessment | subject developed a wound infection following her surgery |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Warner K. Huh, MD | University of Alabama at Birmingham | 205-996-4662 | warner.huh@ccc.uab.edu |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004864 | Equipment and Supplies |
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| >=65 years |
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| Male |
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