Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

NCT02407717 | Completed

• 1 other identifier: ChietiOnco2
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

Hemorrhage; Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer hospitalized for an acute medical illness

You may qualify if:

• all patients with cancer hospitalized for an acute medical illness

You may not qualify if:

• current use of oral or parenteral anticoagulant treatment
• no informed consent to participate

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Hemorrhage; Venous Thrombosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: April 3, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

IT (1)