The aim of the present study is therefore to investigate the commonly used LA lidocaine in its ability to attenuate thrombocyte aggregation in vitro.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is thrombocyte aggregation in vitro in the ASPItest of
MultiPlate, expressed as Area under the Curve (AUC).
Secondary outcome
Secondary objectives of the study are results from three other complementary
tests using MultiPlate, i.e. the TRAPtest and COLtest, which both test the
potential of activation of thrombocytes, and the ADP-test, which tests for
thrombocyte impairment via the ADP pathway (e.g., clopidogrel).
Background summary
Local anesthetics (LA) are widely used in regional anesthesia and multimodal
pain management. LA may directly interact with the coagulation cascade at the
plasmatic and cellular level. Evidence for this assumption comes from clinical
trials and experimental studies. Platelet aggregation seems to be inhibited by
amide-type LA. Potential mechanisms include the inhibition of alpha-granule
release, inhibition of calcium-dependent coagulation processes, and the
interaction with Thromboxane A2-mediated platelet aggregation, corresponding to
a weak aspirin-like effect. However, some of these results were obtained in
non-platelet cell lines, and more detailed mechanisms have not been described.
Moreover, investigations using the novel diagnostic device, MultiPlate®, have
not been carried out.
Study objective
The aim of the present study is therefore to investigate the commonly used LA
lidocaine in its ability to attenuate thrombocyte aggregation in vitro.
Study design
In vitro experiments in whole blood collected from healthy volunteers.
Intervention
The only intervention in volunteers is the drawing of 12 ml of whole blood via
venipuncture. Intervention will take place in vitro: Incubation will be
performed with lidocaine at concentrations between 5 and 100 mcg/ml for 1 hour
at 37 degrees Celsius, followed by MultiPlate measurements.
Study burden and risks
The only intervention is to draw 12 ml of blood from healthy volunteers. No
intervention in volunteers takes place.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers, aged 18-65, ASA status I.
Exclusion criteria
History of abnormal bleeding, ingestion of coagulation imparing drugs, pre-existing disease of heart, lungs, vessels, kidneys or liver.
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 | NL37869.018.11 |