Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Risk Factors for Thromboembolism
- Conditions
- CancerThromboembolismCancer Diagnosis
- Registration Number
- NCT04246073
- Lead Sponsor
- Hellenic Society of Surgical Oncology
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Upcoming surgery for newly diagnosed or potential cancer or relapse / metastasis of cancer that has been treated and diagnosed ≥ 1 year
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of incidents One Year Observed number of incidents per cancer type
Number of bleeding episodes One Year The incidence of bleeding episodes by type of cancer
Comparison of results/incidents among groups One Year 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)
Evaluation One Year Evaluation of antithrombotic treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ioannis Karaitianos
🇬🇷Athens, Attica, Greece