Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemorrhage
- Sponsor
- G. d'Annunzio University
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Major bleeding and clinically relevant non major bleeding
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Marcello Di Nisio
Principal Investigator
G. d'Annunzio University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- 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)