Venous ThrombosisPhase 3NCT00539942
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
A Phase 3 study testing Arixtra (fondaparinux sodium) and Intermittent compression devices (ICD) in people with Venous Thrombosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Arixtra (fondaparinux sodium) and Intermittent compression devices (ICD)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB, Women's and Infant Center, 1700 6th Avenue South
Birmingham, Alabama, 35233
About this study
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
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.
Read the detailed description
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.
- Conditions
- Venous Thrombosis
- Being tested
- Arixtra (fondaparinux sodium), Intermittent compression devices (ICD)
- Keywords
- Randomized Clinical Trials, Randomized Controlled Trial, Venous thrombosis, Anticoagulant Drugs, Doppler Ultrasound, Postoperative complications
- Medical subject headings
- Venous Thrombosis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Arixtra (fondaparinux sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (1)
Incidence of Untoward Effects With Arixtra
Adverse events will be evaluated to determine untoward effects.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Problems with accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Warner Huh, University of Alabama at Birmingham
- Investigators
- Warner K. Huh, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539942
- Sponsor's protocol ID
- F070727009
- Other IDs
- UAB 0723
- Status last verified
- Feb 2017
- First submitted
- 3 Oct 2007
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00539942
- Acronym / sponsor ID
- F070727009
- Conditions
- Venous Thrombosis
- Keywords
- Randomized Clinical Trials, Randomized Controlled Trial, Venous thrombosis, Anticoagulant Drugs, Doppler Ultrasound, Postoperative complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems with accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Posted 9 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent compression devices (ICD) | Active comparator | 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. |
| Arixtra (fondaparinux sodium) | Experimental | Drug: 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). |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Arixtra (fondaparinux sodium) |
| 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) |
Primary outcome
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.
1 secondary outcome
Incidence of Untoward Effects With Arixtra
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warner K. Huh, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arixtra (fondaparinux sodium) and Intermittent compression devices (ICD) in people with Venous Thrombosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.