Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

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

Completed

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Key information

Conditions

Bleeding as Complication to Anticoagulation Therapy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital University of Copenhagen

Hvidovre, 2650, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients admitted for GI bleeding while in treatment with NOAC

Exclusion criteria

none

Treatment and study plan

Primary outcomes

Proportion of patients admitted with adverse event reported to authorities

Time frame: Within one year of admission

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 8, 2014
Registry last updated: Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed