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

Sponsor
Hellenic Society of Surgical Oncology (Other)
Overall Status
Unknown status
CT.gov ID
NCT04246073
Collaborator
(none)
400
Enrollment
1
Location
22
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Identification of the Most Relevant Risk Factors for Thromboembolism
    Actual Study Start Date :
    Feb 1, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Number of incidents [One Year]

      Observed number of incidents per cancer type

    2. Number of bleeding episodes [One Year]

      The incidence of bleeding episodes by type of cancer

    3. 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)

    4. Evaluation [One Year]

      Evaluation of antithrombotic treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ioannis Karaitianos Athens Attica Greece 15562

    Sponsors and Collaborators

    • Hellenic Society of Surgical Oncology

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hellenic Society of Surgical Oncology
    ClinicalTrials.gov Identifier:
    NCT04246073
    Other Study ID Numbers:
    • 1787/11-2-2019
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    Jul 31, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hellenic Society of Surgical Oncology
    Cancer
    Cancer Diagnosis
    Thromboembolism
    Additional relevant MeSH terms:
    Thromboembolism
    Disease

    Study Results

    No Results Posted as of Jul 31, 2020