Clinical trial · Interventional
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
NCT00381888CI-TRIAL-00030967completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer. PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Thromboembolism | — | UNRESOLVED | — |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fondaparinux sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients Treated with Fondaparinux
- description
- Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
- interventionNames
- Drug: fondaparinux sodium
Primary outcomes (1)
- measure
- Number of Patients With Venous Thromboembolism at Week 4
- timeFrame
- Week 4 (Days 28-35)
- description
- Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
Secondary outcomes (1)
- measure
- Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Scheduled to undergo major, open abdominal-pelvic surgery for known or presumed gynecologic malignancy * Age 18 years or older at the time of signing the consent * Gynecologic Oncology Group (GOG) performance status of ≤ 2 * Life expectancy of \> 3 months * Patient's weight must be ≥ 50 kg * Adequate organ function within 28 days of study entry defined as: * Hemoglobin ≥ 9.0 g/dL * Platelet ≥ 100,000 x 109/L * Blood urea nitrogen (BUN) ≤ 30 mg/dL * Serum creatinine ≤ 1.5 mg/dL * Not pregnant as determined by a negative urine or serum pregnancy test within 14 days of study enrollment * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria * Current treatment with anticoagulants * Thromboembolism within the previous 6 months * Bleeding/blood disorders (e.g., thrombocytopenia), gastrointestinal bleeding (e.g., active ulcers), history of stroke within past 3 years, or severe and currently uncontrolled high blood pressure * Bacterial endocarditis * Known hypersensitivity to fondaparinux sodium
References
Publications (0)
Data not yet available
No reference posted for this study.