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

• Conditions: atrial fibrillation; venous thrombosis; 10064477; 10007521

• Registration Number: NL-OMON48347
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>After this project we know the within, between and analytical individual<br /><br>variation, which can be used as criteria for analyses in patients on long-term<br /><br>treatment with Dabigatran.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To provide recommendations for analytical performance specifications for<br /><br>laboratory tests used for the diagnosis, follow-up, and monitoring of the<br /><br>treatment of thrombosis and bleeding</p><br>