The primary objective is to identify which coagulation factors are associated with unsuccessful reversal of VKA activity. Secondary objectives include the assessment of the number of patients reaching normalized INR (i.e.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
stollingsfysiologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma concentrations of prothrombin and factor VII at the day of the invasive
procedure.
Secondary outcome
- The number of patients with an INR <1.8 just prior to the invasive procedure.
- Number of thromboembolic or bleeding events occurring within 30 days after
the intervention.
- Time to achieve therapeutic INR in acenocoumarol users who are administered a
single dose of vitamin K 36-48 hours before the invasive procedure.
- Pharmacogenetic variation between the patients that reach an adequate INR and
those that don't.
Background summary
Patients using vitamin K antagonists (VKAs) need to have the anticoagulant
effect reversed prior to invasive procedures in order to prevent bleeding
complications to occur. At Gelderse Vallei Hospital (ZGV), these patients are
administered 10 mg of vitamin K 36-48 hours prior to the invasive procedure.
Currently, there is no insight what factors cause this strategy to be
successful.
Study objective
The primary objective is to identify which coagulation factors are associated
with unsuccessful reversal of VKA activity. Secondary objectives include the
assessment of the number of patients reaching normalized INR (i.e. <1.8) and
the number of patients experiencing either thromboembolic or bleeding
complications; pharmacogenetics of GGCX.
Study design
Observational study with additional blood draws.
Study burden and risks
Patients do not benefit individually from participating in this study. The
burden of this study encompasses four additional blood draws and is therefore
associated with negligible risk of injury.
Willy Brandtlaan 10
Ede 6716 RP
NL
Willy Brandtlaan 10
Ede 6716 RP
NL
Listed location countries
Age
Inclusion criteria
Patients on acenocoumarol requiring an invasive procedure
Exclusion criteria
- Age < 18 years.
- Patients requiring periprocedural bridging therapy according to our local protocol based on national guidelines with low-molecular-weight-heparin (LMWH).
- Inherited or acquired coagulopathies.
- Inability or incompetency to give informed consent.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2018-002291-41-NL |
| CCMO | NL63929.081.18 |