Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

NCT ID: NCT02407717

Last Updated: 2019-08-08

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

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-07-31

Brief Summary

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Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.

Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.

The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.

Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge

Detailed Description

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Conditions

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Hemorrhage Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* all patients with cancer hospitalized for an acute medical illness

Exclusion Criteria

* current use of oral or parenteral anticoagulant treatment
* no informed consent to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Marcello Di Nisio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ChietiOnco2

Identifier Type: -

Identifier Source: org_study_id

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