Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Completed

• Conditions: Vein Thrombosis; Hemorrhage

• Registration Number: NCT02407717
• Lead Sponsor: G. d'Annunzio University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-30
• Study Start: 2015-04
• Study First Posted: 2015-04-03
• Primary Completion: 2017-08
• Study Completion: 2018-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major bleeding and clinically relevant non major bleeding	Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcome Measures

Name	Time	Method
Minor bleeding	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Venous thromboembolism	Participants will be followed up to 3 months after discharge, an expected average of 13 weeks

Trial Locations

Locations (1)

Universita degli Studi G. d'Annunzio Chieti e Pescara; 🇮🇹 Chieti, Italy