The aims are: 1. Test whether a POCT INR can be used in a clinical setting compared to five regular central assays (including the in-house method) and with the tilt tube / WHO standard as reference INR. 2. To establish possible causes for…
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Brief title
Condition
- Other condition
Synonym
Health condition
het betreft patiënten die op de afdeling cardiologie behandeld worden met antistollingsmiddelen ter preventie van trombotische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Using error grid analysis1 a maximal allowable bias of 20% between the
reference method and another INR assay will be allowed.
Secondary outcome
Discrepancies between assays will be investigated by measuring coagulation
factor levels and, if present, the anti-Xa activity due to the presence of
heparin or LMWH.
Background summary
Oral anticoagulant (OAC) treatment is based upon a laboratory assay, the
prothrombin time (PT), expressed as international normalised ratio (INR) to
standardize the PT results between reagents of various companies. The INR for
clinical patients in the AMC is presently measured centrally at the Laboratory
General Clinical Chemistry (LAKC) with a regular INR assay (in-house method),
which results in turn-around-times of the lab. result of approximately one hour
after sample arrival. Already some years, Point-of-care testing (POCT) of the
INR is available, but is solely in use for the outpatient situation. Also, in
spite of the INR standardization, the INR results vary somewhat between regular
INR assays because the reagents in use have different sensitivities for
coagulation factor levels in the patient plasma and because some reagents
contain heparinase to reduce the effect of co-medication with heparin or
low-molecular-weight heparin (LMWH). Proper evaluation of the POCT and the
regular INR assays with the reference method (WHO reagent and manual tilt tube
assay) has not yet been performed with material derived from hospitalised
patients.
Study objective
The aims are: 1. Test whether a POCT INR can be used in a clinical setting
compared to five regular central assays (including the in-house method) and
with the tilt tube / WHO standard as reference INR. 2. To establish possible
causes for differences between the regular INR assays and with the POC test.
Study design
The nurses of the Cardiology department will collect 2.7 ml venous blood (plus
an additional 5.4 mL) for the regular laboratory assays as usual and perform an
extra *finger prick* for the POCT INR. Anticoagulant co-medication (heparin or
low-molecular-weight heparin [LMWH] levels) will be determined in all venous
blood samples, and coagulation factor levels in samples with discrepant INR
assay results.
Study population: Patients who stay at the Cardiology department and undergo
oral anticoagulation therapy.
Study burden and risks
Patients will have an additional capillary blood drawn from their finger, plus
5.4 mL extra venous blood collection, performed during the routine sampling in
patient care.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Treated with anticoagulation medication
Inpatient in cardiology department
Exclusion criteria
No fingers available for fingerprick
Terminally ill
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 | NL36304.018.11 |