Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

Bleeding as Complication to Anticoagulation Therapy Clinical Trial

Official title:

Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107651
• Other study ID #: 01675-HVH-2012-010-999
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: April 23, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Serious adverse events in patients treated with new oral anticoagulants are underreported.

Description:

The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients admitted for GI bleeding while in treatment with NOAC

Exclusion Criteria:

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Bleeding as Complication to Anticoagulation Therapy

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital University of Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients admitted with adverse event reported to authorities		Within one year of admission	No