This study aims at establishing the influence of sampling site on the variability of ACT measurement at the end ofcoronary angiography or PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Variability in ACT measurements at different blood sampling sites at the end of
coronary angiography or intervention in
patients receiving pre-procedural UFH.
Secondary outcome
N.A.
Background summary
The current era of coronary angiography and intervention in a progressively
aging and frail population- bids for a feasible and clear protocol regarding
the adiministration of UFH and measuring its level of anticoagulation. The
activated clotting time (ACT) reflects UFH activity and has been used for
decades to monitor or adjust heparin dosage.1 However, no definite guidelines
regarding ACT measurements exist. The ACT measurements could be obtained from
venous as well as arterial blood samples. Theoretically, sampling blood from
heparin-coated access
sites (i.e. arterial sheath, diagnostic or guiding catheter) might influence
ACT measurement and result in an incorrect representation of coagulation level.
It goes within saying that underestimation or overestimation of coagulation
level might jeopardize adequate coronary treatment and patient well-being.
Study objective
This study aims at establishing the influence of sampling site on the
variability of ACT measurement at the end of
coronary angiography or PCI.
Study design
Prospective, single-center observational study
Study burden and risks
The burden of participation solely consists of obtaining extra blood from the
three sample sites (i.e. approximately 10cc
of blood). Therefore, there are no risks in participation, but benefit is also
small since the treatment does not differ from
routine practice.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
Consecutive patients scheduled for diagnostic coronary angiography or elective percutaneous coronary intervention (PCI) are screened for entry into this study. Patient are eligible for this study when it is expected that the scheduled procedure will be accomplished with a single bolus of heparin, i.e. patient undergoing a procedure with expected duration of > 1 hour will not be included in this study.
Exclusion criteria
- Use of novel oral anticoagulants or vitamin K antagonists
- Chronic use of non-steroid anti-inflammatory drugs with the exception of aspirin
- Known renal insufficiency (e.g. serum creatinine level of more than 265 *mol/L (i.e. more than 3.5 mg/L))
- Liver function disorders with coagulopathies (PT >1.5N, INR >2.0 and/or thrombocyte count < 100 x 109/L)
- Suspicion of unstable coronary artery disease with chest pain in rest, ECG changes, elevated cardiac markers, or hemodynamic instability at the time of the procedure
- Unability to read and understand the Dutch language
- Previous participation in this study
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 | NL63160.094.17 |