Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Risk Factors for Thromboembolism

Study Overview
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Brief Summary
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Non interventional multi-centric study that will aim in evaluating the efficacy and safety of Fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for Thromboembolism.

Detailed Description
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Non interventional multi-centric study that will aim in evaluating the efficacy and safety of Fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for Thromboembolism. It is a cohort study, recruiting cancer patients over 18 years of age, who have been diagnosed with cancer for over a period of one year. Exclusion criteria apply as well while all patients can withdraw their participation at any time point.

Official Title
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Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Identification of the Most Relevant Risk Factors for Thromboembolism

Conditions
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Cancer Diagnosis, Thromboembolism, Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upcoming surgery for newly diagnosed or potential cancer or relapse / metastasis of cancer that has been treated and diagnosed ≥ 1 year Exclusion Criteria: Recent (<6 months) episode of venous thromboembolic disease (Deep vein thrombosis and / or pulmonary embolism and / or thrombosis in a rare location such as visceral or cerebral venous thrombosis) Pregnancy or pregnancy Patients on long-term anticoagulation for any reason (MKH, HMB or ABK, DOACs) at prophylactic or therapeutic dose, prior to enrollment in the study. Active haemorrhage, diagnosed hemorrhagic disorder, thrombocytopenia Ulcers or vasodilatations of the gastrointestinal tract Hemorrhagic stroke or surgery in the brain, spine or eye of the last trimester Bacterial endocarditis or other contraindication to the use of anticoagulant treatment Creatinine clearance <20mL / min Thrombolytic treatment or administration of dextran in the 2 days preceding administration of fondaparinux

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incidents | Observed number of incidents per cancer type | One Year | 
| Number of bleeding episodes | The incidence of bleeding episodes by type of cancer | One Year | 
| Comparison of results/incidents among groups | Results of treatment in subgroups of patients (for example patients with newly diagnosed cancer or potential cancer or relapse / metastasis of cancer that has been treated before and diagnosed ≥ 1 year) | One Year | 
| Evaluation | Evaluation of antithrombotic treatment | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Cancer Diagnosis, Thromboembolism