Anticoagulation Clinical Trial
Official title:
Prospective Trial of a Validated Algorithm for Warfarin Dosing
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.
Status | Completed |
Enrollment | 211 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aalborg Universitetshospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time in therapeutic range | The primary study endpoint, TTR, was calculated according to the Rosendaal method | 6 months | Yes |
Secondary | Log of the variance growth rate | As a measure of INR variability we used log of the variance growth rate (logVGR) defined by Fihn et al. | 6 months | Yes |
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