Evaluation of the Risk of VTE Among Patients Hospitalized in Non-surgical Departments

Thromboembolism Clinical Trial

Official title:

The Risk for VTE Among Patients in the Medical Wards - Prospective Observational Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03073915
• Other study ID #: 0090-08-HMO
• Status: Active, not recruiting
• Start date: August 2013
• Est. completion date: December 2020

Study information

• Verified date: March 2018
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE. Yet several retrospective studies have shown that the compliance with this guideline is low. Physicians are often reluctant to administer LMWH to their fragile patients mainly because they are not convince that the risk associated with such therapy is greater than the risk for VTE.

In the current study, data concerning the use of thromboprophylaxis among patients admitted to the medical wards will be collected. The occurrence of bleeding or thrombotic event will be evaluated prospectively.

Description:

Data concerning the use of LMWH among patients admitted to the medical wards at the Hadassah University Hospital will be collected prospectively from the electronic medical records. The occurrence of bleeding episodes or thrombotic events will be followed for the next 90 days following discharge from the hospital.

The percent of patients actually treated by LMWH among patients entitled for such therapy according to the most updated international guidelines will be evaluated. The risk of minor and major bleeding will be compared among those given thromboprophylaxis and those who were not treated. Similar comparison will be made for thrombotic events.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients admitted to the medical wards at the Hadassah University Hospital

Exclusion Criteria:

Related Conditions & MeSH terms

• Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombosis	Rate of thrombotic events within 90 days following discharge	90 days
Primary	Bleeding	Rate of minor and major bleeding episodes within 90 days following discharge	90 days
Primary	Compliance	Rate of compliance with ACCP guidelines concerning thromboprophylaxis of non-surgical patients.	90 days