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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Thromboembolism; Cancer Diagnosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 15562
      • Recruiting
      • Ioannis Karaitianos
      • Contact: Ioannis G Karaitianos, Study Director; Phone Number: +30 6932401823; Email: igkaraitianos@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of incidents	Observed number of incidents per cancer type	One Year
Number of bleeding episodes	The incidence of bleeding episodes by type of cancer	One Year
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
Evaluation	Evaluation of antithrombotic treatment	One Year

Collaborators and Investigators

• Sponsor: Hellenic Society of Surgical Oncology
• Investigators: Study Director: Ioannis G Karaitianos, Hellenic Society of Surgical Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Thromboembolism; Cancer Diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: 1787/11-2-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No