Excessive Warfarin Anticoagulation - Causes and Consequences

NCT ID: NCT02761941

Last Updated: 2016-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anticoagulation

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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Inclusion Criteria

* VKA treatment, age \> 18, INR \>9,

Exclusion Criteria

* age \< 18
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Juhani Airaksinen

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juhani Airaksinen, Professor

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Tuija Vasankari, RN

Role: CONTACT

+358 2 3130900

Facility Contacts

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Juhani Airaksinen, prof

Role: primary

+35823131005

Tuomas Kiviniemi, MD, PhD

Role: backup

+35823130787

Other Identifiers

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T80/2016

Identifier Type: -

Identifier Source: org_study_id

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