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NCT00381888 · REGISTRY CONDITION SEARCH

Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-12-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Venous Thromboembolism at Week 4

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outcome · POSTED

Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
    intervention Names
    1. Drug: fondaparinux sodium
    label
    Patients Treated with Fondaparinux
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Patients Treated with Fondaparinux
    description
    Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
    name
    fondaparinux sodium
    other Names
    1. Artixtra(R)
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
44
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
    measure
    Number of Patients With Venous Thromboembolism at Week 4
    time Frame
    Week 4 (Days 28-35)
secondary Outcomes
  1. description
    This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.
    measure
    Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
    time Frame
    Week 4
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery. Secondary * Evaluate the safety of this regimen in these patients (4 weeks). * Determine the feasibility of this regimen in these patients (4 weeks). OUTLINE: This is an open-label study. Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo duplex ultrasonography of the lower extremities between day 28-35.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      source kind
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      payload
      clinical indication matching status
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      id
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      occurrences
      1. context exact
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        exact text
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      offset unit
      unicode_code_points
      query cond
      Vaginal Cancer
      query disease state id
      ds-vaginal-cancer
      source file
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      payload sha256
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      query cond
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      query disease state id
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      source file
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      requested nct id
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      payload sha256
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      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
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      payload sha256
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      query cond
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      query disease state id
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      source file
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        exact text
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice