Excessive Warfarin Anticoagulation - Causes and Consequences (EWA)

U

University of Turku

Status

Unknown

Conditions

Anticoagulation

Study type

Observational

Funder types

Other

Identifiers

NCT02761941
T80/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

25,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

VKA treatment, age > 18, INR >9,

Exclusion criteria

age < 18

Trial contacts and locations

1

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Central trial contact

Tuija Vasankari, RN

Data sourced from clinicaltrials.gov

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