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Excessive Warfarin Anticoagulation - Causes and Consequences (EWA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 3, 2016
First Posted Date May 4, 2016
Last Update Posted Date May 5, 2016
Study Start Date May 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2016)
All cause mortality [ Time Frame: 90 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Excessive Warfarin Anticoagulation - Causes and Consequences
Official Title Excessive Warfarin Anticoagulation - Causes and Consequences
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Target Follow-Up Duration 90 Days
Biospecimen Not Provided
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.
Condition Anticoagulation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 3, 2016)
25000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • VKA treatment, age > 18, INR >9,

Exclusion Criteria:

  • age < 18
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02761941
Other Study ID Numbers T80/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Juhani Airaksinen, University of Turku
Study Sponsor University of Turku
Collaborators Not Provided
Investigators
Principal Investigator: Juhani Airaksinen, Professor Turku University Hospital
PRS Account University of Turku
Verification Date May 2016