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

NCT ID: NCT04246073

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Cancer Cancer Diagnosis Thromboembolism

Keywords

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Cancer Cancer Diagnosis Thromboembolism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Society of Surgical Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioannis G Karaitianos

Role: STUDY_DIRECTOR

Hellenic Society of Surgical Oncology

Locations

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Ioannis Karaitianos

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Ioannis G Karaitianos, Study Director

Role: CONTACT

Phone: 6932401823

Email: [email protected]

Facility Contacts

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Ioannis G Karaitianos, Study Director

Role: primary

Other Identifiers

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1787/11-2-2019

Identifier Type: -

Identifier Source: org_study_id