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OpenTrials
Completed

NCT Number: NCT02407717

Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

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

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Key information

Conditions

Hemorrhage Cardiovascular Diseases Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Vein Thrombosis Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, 66100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major bleeding and clinically relevant non major bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary outcomes

  1. Venous thromboembolism

    Time frame: Participants will be followed up to 3 months after discharge, an expected average of 13 weeks

  2. Minor bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 3, 2015
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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