Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

April 23, 2014 updated by: Thue Bisgaard, Hvidovre University Hospital

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted for GI bleeding while in treatment with NOAC

Description

Inclusion Criteria:

  • patients admitted for GI bleeding while in treatment with NOAC

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NOAC
Patients admitted for GI bleeding while in treatment with NOAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients admitted with adverse event reported to authorities
Time Frame: Within one year of admission
Within one year of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Bisgaard Thue, Ph.D, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01675-HVH-2012-010-999

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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