Clinical trial NCT04246073: Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Risk Factors for Thromboembolism
Official title: Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Identification of the Most Relevant Risk Factors for Thromboembolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Cancer Diagnosis
Thromboembolism
Keywords: Cancer
Cancer Diagnosis
Thromboembolism
Lead sponsor: Hellenic Society of Surgical Oncology
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multi centered, non interventional study with inclusion and exclusion criteria as described in the above section. Due to the fact that this is an observational study the results of all correlations will be carefully discussed and will used only for the evaluation of cases.Patients' participation in the study may be interrupted at any time.

The reasons for the interruption could be as follows:

1. Withdrawal of patient consent
2. Incorrect enrollment in the study, ie the patient does not meet the inclusion / exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of incidents
timeFrame: One Year
measure: Number of bleeding episodes
timeFrame: One Year
measure: Comparison of results/incidents among groups
timeFrame: One Year
measure: Evaluation
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Ioannis Karaitianos
state: Attica
Study officials:
affiliation: Hellenic Society of Surgical Oncology
name: Ioannis G Karaitianos
role: STUDY_DIRECTOR
References: