Exploratory study to assess frailty as a clinical marker for the plasma concentrations of the direct oral anticoagulants (Frailty-DOAK)
Recruiting
- Conditions
- FrailtyR54Senility
- Registration Number
- DRKS00016741
- Lead Sponsor
- Agaplesion Bethanien Krankenhaus Geriatrisches Zentrum der Universität Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
•Age =70 years
•Regular intake of one of the direct oral anticoagulants dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) or edoxaban (Lixiana®) during the past = 7 days
•Mentally and physically able to participate in the study (as judged by a member of the study group)
•Written informed consent
Exclusion Criteria
•Insufficient knowledge of written and/or spoken German
•Inability to give informed consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Correlation of four frailty assessments with the plasma trough concentrations of four direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) <br>-„Physical phenotype of frailty (Fried et al. 2001) <br>-Frailty Index (Searle et al. 2008)<br>-„FRAIL scale (Morley et al. 2012)<br>-„Short Physical Performance Battery (SPPB)<br>•Evaluation of the three groups „frail, „pre-frail and „robust according to Fried et al. 2001 as to their ability to predict the plasma trough concentrations of the direct oral anticoagulants<br>
- Secondary Outcome Measures
Name Time Method •Correlation of selected functional parameters (e.g. gait speed, grip strength) with the plasma trough concentrations of four direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban)