Prospective Evaluation of Efficacy and Safety of Fondapar... | NCT04246073

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

NCT04246073

Sponsor

Hellenic Society of Surgical Oncology

Status

Unknown status

Last Update Posted

Jul 31, 2020Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Cancer
Cancer Diagnosis
Thromboembolism

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jan 27, 2020

First Submission Date that Met QC Criteria

Jan 27, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Jul 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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:

Withdrawal of patient consent
Incorrect enrollment in the study, ie the patient does not meet the inclusion / exclusion criteria

Sampling Method

Non-Probability Sample

ID	Term
D009369	Neoplasms
D013923	Thromboembolism

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases