Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02407717

Enrollment

330

Registered

2015-04-03

Start date

2015-04-30

Completion date

2018-07-31

Last updated

2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage, Vein Thrombosis

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Italy

Outcome results