to determine the immediate effects of alcohol consumption in healthy volunteers on haemostasis and to evaluate the differences of artificially alcoholised blood and *naturally*, via oral uptake alcoholised blood on haemostasis as measured by…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
thromboelastographic variables
alcohol promillage
the prothrombin time
activated partial thromboplastin time
plasma fibrinogen level
platelet count
hematocrit
Secondary outcome
NA
Background summary
The blood clotting characteristics of healthy individuals who recently consumed
alcohol may have important clinical consequences. These individuals are often
seen as patients in trauma settings and optimal administration of blood
products depends on clotting characteristics.
A number of studies have shown that alcohol consumption is an important
contributing factor for injuries among patients seeking for emergency care [1,
2]. Drinking in the event of injury has been found to be related to falls,
intentional injuries and transit related injuries. These patients are often
sent immediately to the operation theatre for a surgical procedure and may
loose more blood compared to sober patients and hence are exposed to the
negative effects of administered blood products in addition to higher costs.
Study objective
to determine the immediate effects of alcohol consumption in healthy volunteers
on haemostasis and to evaluate the differences of artificially alcoholised
blood and *naturally*, via oral uptake alcoholised blood on haemostasis as
measured by thromboelastography.
Study design
clinical observational mono-center study
Intervention
the consumption of three alcoholic beverages (800mg/kg ethanol) of either beer
or wine compared to the consumption of water.
Study burden and risks
Subjects consume 3 units of alcohol. One blood sample of 39 ml followed by 5
samples of 21 ml will be drawn between 17.00 hours and 18.00 hours
respectively. All observations take place in a single visit. It is unlikely
that subjects will experience any physical or psychological discomfort from the
total 144 ml blood sample. The volunteers will fast for six hours prior to the
first blood sample to obtain a reliable blood ethanol concentration. After
sampling at 22.00 hours volunteers are offered a warm meal and care will be
taken for transportation homewards.
hanzeplein 1, Groningen
9713 GZ
Nederland
hanzeplein 1, Groningen
9713 GZ
Nederland
Listed location countries
Age
Inclusion criteria
male
age between 25 and 50 years
informed consent
Exclusion criteria
use of any medication
history of haemostatic disorder
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 | NL32346.042.10 |