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

Hellenic Society of Surgical Oncology

Status: Unknown

Conditions: Thromboembolism; Cancer Diagnosis; Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04246073

1787/11-2-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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