Biological variation (BIOVAR) study: Performance specifications for laboratory analysis of haemostasis variables in patients with long-term treatment with Dabigatran.

Biological variation (BIOVAR) study: Performance specifications for laboratory analysis of haemostasis variables in patients with long-term treatment with Dabigatran. - BIOVAR study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48347

Enrollment

Registered

2019-05-07

Start date

2019-01-02

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation venous thrombosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male and female patients, aged 18-70 years of age with atrial fibrillation or venous thrombosis. * Patients with long-term Dabigatran use on a stable dosage for a minimum of 3 months. * Given written informed consent.

Exclusion criteria

Exclusion criteria: * Subjects with any malignancies * Positive lupus anticoagulant. * Body mass index (BMI)>30 kg/m2. * Glomerular Filtration Rate (GFR)

Design outcomes

Primary

Measure	Time frame
After this project we know the within, between and analytical individual variation, which can be used as criteria for analyses in patients on long-term treatment with Dabigatran.	—

Secondary

Measure	Time frame
To provide recommendations for analytical performance specifications for laboratory tests used for the diagnosis, follow-up, and monitoring of the treatment of thrombosis and bleeding	—

Countries

Netherlands

Outcome results