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Excessive Warfarin Anticoagulation - Causes and Consequences

Excessive Warfarin Anticoagulation - Causes and Consequences

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02761941
Acronym
EWA
Enrollment
25000
Registered
2016-05-04
Start date
2016-05-31
Completion date
2019-12-31
Last updated
2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation

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.

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.

Interventions

None listed

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* age \< 18

Design outcomes

Primary

MeasureTime frame
All cause mortality90 days

Countries

Finland

Contacts

Primary ContactTuija Vasankari, RN
tuija.vasankari@tyks.fi+358 2 3130900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026