Cancer, Cancer Diagnosis, Thromboembolism
Conditions
Keywords
Cancer, Cancer Diagnosis, Thromboembolism
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.
Interventions
None listed
Sponsors
Hellenic Society of Surgical Oncology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Contacts
Primary ContactIoannis G Karaitianos, Study Director
Outcome results
None listed