Choosing the most suitable laboratory test and setting up a gold standard test to measure dabigatran. Additionally, determining maximal and minimal concentrations of the drug.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Several clotting tests are compared with each other and the gold standard to
select the best test.
Secondary outcome
To determine target values for dabigatran concentrations with different dosage
regimes
Background summary
New oral anticoagulant drugs have become available for several applications.
Dabigatran is one of these drugs that is already used in daily practice. The
pharmacokinetics and pharmacodynamics of these drugs are more predictable so
that monitoring with laboratory tests seems redundant. However, this assumption
is based on studies that have used extensive patient selection. More recent
studies have shown that several categories of patients might need individual
adaptation of dosage or monitoring, for instance in the case of extremely high
or low body weight or low glomerular filtration rate. Moreover, in acute
situations, for example in case of suspected overdose or acute surgery and when
compliance is questioned, accurate laboratory tests will be necessary.
Study objective
Choosing the most suitable laboratory test and setting up a gold standard test
to measure dabigatran. Additionally, determining maximal and minimal
concentrations of the drug.
Study design
observational study
Study burden and risks
Venipuncture for blood collection at three different time points (right before
taking the next dose and 2 and 4 hours after taking the next dose), with a
small risk of bruising or bleeding
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Patients using dabigatran (CZE hospital) or rivaroxaban (MMC hospital) in a profylactic dose
Exclusion criteria
renal failure (GFR <30 ml/min), use of antiplatelet agents, previous malignancy, use of other oral anticoagulants (cumarins), age <18 years
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 | NL42009.060.12 |