Clinical trial · Interventional
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Problems with accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Venous Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arixtra (fondaparinux sodium) | Drug | — | UNRESOLVED |
| Intermittent compression devices (ICD) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intermittent compression devices (ICD)
- 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.
- interventionNames
- Device: Intermittent compression devices (ICD)
- type
- EXPERIMENTAL
- label
- Arixtra (fondaparinux sodium)
- 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).
- interventionNames
- Drug: Arixtra (fondaparinux sodium)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available