Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Hemorrhage Clinical Trial

Official title:

Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407717
• Other study ID #: ChietiOnco2
• Status: Completed
• Start date: April 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2019
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Thromboembolism
• Thrombosis
• Vein Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
Italy	Universita degli Studi G. d'Annunzio Chieti e Pescara	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Venous thromboembolism		Participants will be followed up to 3 months after discharge, an expected average of 13 weeks
Secondary	Minor bleeding		Participants will be followed for the duration of hospital stay, an expected average of 1 week