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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246073
• Other study ID #: 1787/11-2-2019
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: Hellenic Society of Surgical Oncology
• Contact: Ioannis G Karaitianos, Study Director
• Phone: 6932401823
• Email: igkaraitianos[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Diagnosis
• Thromboembolism

Locations

Country	Name	City	State
Greece	Ioannis Karaitianos	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Society of Surgical Oncology

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incidents	Observed number of incidents per cancer type	One Year
Primary	Number of bleeding episodes	The incidence of bleeding episodes by type of cancer	One Year
Primary	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
Primary	Evaluation	Evaluation of antithrombotic treatment	One Year