The aim of this longitudinal study is to investigate the biological variation of haemostasis variables involved in thrombosis and bleeding in patients on long-term treatment with Dabigatran. This may enable us to provide recommendations for…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Outcome of diagnostic screenings in haemostasis laboratories on blood
parameters is affected by analytical or biological variation. Biological
variation, within and between individuals, and analytical variation of
diagnostic instruments, is now assessed using data of healthy individuals.
Preferably, analytical criteria for both internal and external quality control
should be based on biological variation in patients instead of healthy
volunteers. Patients using the Direct Oral Anticoagulant (DOAC), Dabigatran may
have a different biological variation than healthy volunteers.
Study objective
The aim of this longitudinal study is to investigate the biological variation
of haemostasis variables involved in thrombosis and bleeding in patients on
long-term treatment with Dabigatran. This may enable us 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.
Study design
We intend to do a longitudinal descriptive study with repeated blood collection
(in total 10 times during a 1-year period).
Study burden and risks
Patients will be asked to donate 10 ml of blood 10 times during a 1-year
period. The burden will be minimized when possible, blood sample collection
will be combined as much as possible with outpatient clinic visits and regular
care blood drawings. As this is an observational study, there is no direct
benefit for patients during the study period. However, the results of this
study may benefit patients on long-term treatment with Dabigatran in diagnosis
and treatment of bleeding and thrombosis. The venepuncture is the only
intervention and the study does not change standard care of patients. This
study gives a minimal risk for the patients* health: only complications of a
venepuncture might be expected, which are minimal. DOAC*s are currently
treatment of choice in patients with venous thrombosis and are used as primary
and secondary prevention in patients with atrial fibrillation. To improve the
diagnosis and treatment of patients on Dabigatran, it is thus needed to know
the biological variation of these patients.
Wytemaweg 80
Rotterdam 3015 CE
NL
Wytemaweg 80
Rotterdam 3015 CE
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67304.078.18 |