Anticoagulation
Conditions
Brief summary
The aim of this study is to perform a randomized trial comparing the use of the algorithm, with dosing of warfarin in standard manual dosage clinical practice, in a high quality anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance of the algorithm when used in a clinical setup. The results from the study are expected to increase our knowledge of efficacy by using the algorithm in clinical practice.
Interventions
OTHERExperimental
The algorithm is based on a model, which is designed to handle time series of daily warfarin intakes and INR values measured at designated time points. Based on these inputs the model is able to suggest a warfarin maintenance dose to achieve target INR value. Model parameters are initially set to population values and gradually, as data is entered into the model, these parameters become patient specific.
OTHERActive Comparator
Participants were (previously) educated in monitoring the INR values and to adjust the warfarin treatment accordingly to achieve a designated target INR range.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will be those ≥18 years old, must refer to Trombosecenter Aalborg and have to be educated as PSM patient * Have to be treated for at least 1 month and willing to sign informed consent
Exclusion criteria
* OAT treatment with phenprocoumon * Lack of ability to handle the interface on the software used in the study (evaluated by the investigator present at the information meeting) * Pregnancy * Those with severe co-morbidities (e.g., creatinine \> 2.5, hepatic insufficiency, active malignancy, advanced physiological age, noncompliance risk, expected survival \<6 months), and physician or patient preference.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in therapeutic range | 6 months | The primary study endpoint, TTR, was calculated according to the Rosendaal method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Log of the variance growth rate | 6 months | As a measure of INR variability we used log of the variance growth rate (logVGR) defined by Fihn et al. |
Outcome results
None listed