Excessive Warfarin Anticoagulation - Causes and Consequences (EWA)

May 4, 2016 updated by: Juhani Airaksinen, University of Turku
The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Factors influencing on high INR values will be recorded and the aim is to seek out patients who have elevated risk of bleeding complications.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a retrospective study setting. Source data will be collected by reviewing medical records and through computer searches. The basic study population will be identified from laboratory INR test results taken between 2003-2015.

Identifying patients with INR values over 9 will be selected for further analysis, concerning the clinical presentation, patient characteristics, 90 day survival and adverse event rates. The focus is in identifying patient characteristics and factors influencing the risk of high INR value. Also we will analyse the effects of medically reversing the high INR values on stroke and other adverse event rates. The results will be collected manually using an electronic case report form, and analysed statistically using SPSS/SAS statistics tool.

Study Type

Observational

Enrollment (Anticipated)

25000

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

  • Finland
      • Turku, Finland
        • Recruiting
        • Turku University Hospital
        • Contact:
          • Tuomas Kiviniemi, MD, PhD
          • Phone Number: +35823130787
          • Email: tuoski@utu.fi
        • Contact:
        • Principal Investigator:
          • Juhani Airaksinen, Prof
        • Sub-Investigator:
          • Fausto Biancari, MD, PhD
        • Sub-Investigator:
          • Samuli Jaakkola, MD
        • Sub-Investigator:
          • Ilpo Nuotio, MD, PhD

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 treated with VKA for atrial fibrillation in the Southwest Finland hospital district area with INR value over 9.

Description

Inclusion Criteria:

  • VKA treatment, age > 18, INR >9,

Exclusion Criteria:

  • age < 18

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

  • Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

University of Turku

Investigators

  • Principal Investigator: Juhani Airaksinen, Professor, Turku University Hospital

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

May 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • T80/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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