- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00381888
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Masonic Cancer Center at University of Minnesota
-
-
Pennsylvania
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Upland, Pennsylvania, Forenede Stater, 19013
- Crozer-Chester Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Patients Treated with Fondaparinux
Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
|
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients With Venous Thromboembolism at Week 4
Tidsramme: Week 4 (Days 28-35)
|
Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
|
Week 4 (Days 28-35)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
Tidsramme: Week 4
|
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.
|
Week 4
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Levi S. Downs, MD, Masonic Cancer Center, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Neoplasmer, bindevæv og blødt væv
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Uterine neoplasmer
- Genitale neoplasmer, kvindelige
- Livmoderhalssygdomme
- Livmodersygdomme
- Adnexale sygdomme
- Embolisme og trombose
- Æggeledersygdomme
- Vaginale sygdomme
- Vulva sygdomme
- Sarkom
- Uterine cervikale neoplasmer
- Æggelederneoplasmer
- Endometriale neoplasmer
- Tromboemboli
- Vulva neoplasmer
- Vaginale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Proteasehæmmere
- Faktor Xa-hæmmere
- Antithrombiner
- Serinproteinasehæmmere
- Antikoagulanter
- Fondaparinux
- PENTA
Andre undersøgelses-id-numre
- CDR0000503985
- UMN-2006LS009 (Anden identifikator: Clinical Trials Office, University of Minnesota)
- UMN-0603M82707 (Anden identifikator: IRB, University of Minnesota)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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