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

NCT04246073 | Unknown DMC

• 1 other identifier: 1787/11-2-2019
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Cancer Diagnosis; Thromboembolism

Keywords

Cancer; Cancer Diagnosis; Thromboembolism

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Upcoming surgery for newly diagnosed or potential cancer or relapse / metastasis of cancer that has been treated and diagnosed ≥ 1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Society of Surgical Oncology: lead

Study Sites (1)

Ioannis Karaitianos

Athens, Attica, 15562, Greece

RECRUITING

MeSH Terms

Conditions

Neoplasms; Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ioannis G Karaitianos

  Hellenic Society of Surgical Oncology

  STUDY DIRECTOR

Central Study Contacts

Ioannis G Karaitianos, Study Director

CONTACT

6932401823; igkaraitianos@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: February 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)