Is there an increase in markers of trombogenese (platelet activation, d-dimeer, von willebrandfactor, OPG) in elderly users of antipsychotics six to ten days after the start in comparison to the same markers before start of the antipsychotic…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Central nervous system vascular disorders
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Platelet activation tests
2. D-dimeer
3. Von Willebrand Factor
4. Osteoprotegerine (OPG)
Secondary outcome
Age (in years)
Sexe (male/female)
Comorbidity
In case of dementia, also the seriousness of the dementia according to the
Clinical Dementia Rating scale
In case of Parkinson(ism), also the seriousness according to the Hoehn en Yahr
criteria
Medication
Type antipsychotic
Dosage of the antipsychotic
Indication of prescribing the antipsychotic medication
The medical record will be used as the source for the secundairy study
parameters
Background summary
The food and drug administration notified in 2005 that antipsychotics are
associated with an increased risk of mortality in elderly patients. This fact
can not be explained by more coronary events, but there seem to be more
cerebrovascular events and thrombo-embolic events. A possible explaination is
an increase in thrombogenesis factors in blood. In elderly users of
antipsychotics there is no answer to the question what the mechanism is behind
the increased (cerebro) vascular mortality.
Study objective
Is there an increase in markers of trombogenese (platelet activation, d-dimeer,
von willebrandfactor, OPG) in elderly users of antipsychotics six to ten days
after the start in comparison to the same markers before start of the
antipsychotic medication?
Study design
Prospective study
Study burden and risks
Two times vena puncture
The burden for the patient is low, there are no risks for the participants
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Age above 65 years
start of an antipsychotic drug
informed consent
Exclusion criteria
history of venous tromboemoblism or deep venous thrombosis
malignancy with treatment in the last 6 months or palliative treatment
bedridden or immobilisation for more than tree days
operation in the four previous weeks
delirium or acute psychosis, as indication of use of antipsychotic drug
use of an antipsychotic in the 6 months previous to the start of the studie
other changes in medication within the 10 days of observation
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 | NL38164.041.11 |