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Excessive Warfarin Anticoagulation - Causes and Consequences (EWA)

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ClinicalTrials.gov Identifier: NCT02761941
Recruitment Status : Unknown
Verified May 2016 by Juhani Airaksinen, University of Turku.
Recruitment status was:  Recruiting
First Posted : May 4, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Juhani Airaksinen, University of Turku

Study Description
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Brief Summary:
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.

Condition or disease
Anticoagulation

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Target Follow-Up Duration: 90 Days
Official Title: Excessive Warfarin Anticoagulation - Causes and Consequences
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • VKA treatment, age > 18, INR >9,

Exclusion Criteria:

  • age < 18
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761941


Contacts
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Contact: Tuija Vasankari, RN +358 2 3130900 tuija.vasankari@tyks.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland
Contact: Juhani Airaksinen, prof    +35823131005    juhani.airaksinen@tyks.fi   
Contact: Tuomas Kiviniemi, MD, PhD    +35823130787    tuoski@utu.fi   
Principal Investigator: Juhani Airaksinen, Prof         
Sub-Investigator: Tuomas Kiviniemi, MD, PhD         
Sub-Investigator: Fausto Biancari, MD, PhD         
Sub-Investigator: Samuli Jaakkola, MD         
Sub-Investigator: Ilpo Nuotio, MD, PhD         
Sponsors and Collaborators
University of Turku
Investigators
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Principal Investigator: Juhani Airaksinen, Professor Turku University Hospital
More Information
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Additional Information:

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Responsible Party: Juhani Airaksinen, Professor of Cardiology, University of Turku
ClinicalTrials.gov Identifier: NCT02761941     History of Changes
Other Study ID Numbers: T80/2016
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Warfarin
Anticoagulants