Excessive Warfarin Anticoagulation - Causes and Consequences

Anticoagulation Clinical Trial

— EWA  

Official title:

Excessive Warfarin Anticoagulation - Causes and Consequences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02761941
• Other study ID #: T80/2016
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2016
• Last updated: May 4, 2016
• Start date: May 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2016
• Source: University of Turku
• Contact: Tuija Vasankari, RN
• Phone: +358 2 3130900
• Email: tuija.vasankari[@]tyks.fi
• Is FDA regulated: No
• Health authority: Finland: National Institute for Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• VKA treatment, age > 18, INR >9,

Exclusion Criteria:

• age < 18

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Anticoagulation

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		90 days	Yes