Primary question: What are the riskfacors of VT in the older population?Secondary questions: What is the frequence and seriousness of the PTS in the elderly and which impact has the VT on the QOL and the functionality of this group.
ID
Source
Brief title
Condition
- Age related factors
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The riskfactors of developing VT can be determined. Furthermore specific
riskgroups in developing VT in the elderly can be described.
Secondary outcome
The frequence and seriousness of the post-thrombotic syndrome of the elderly
will be defined, and the quality of life in the elderly can be compared with
the general queality of life in the older population.
Moreover the influence of VT on the functionality of the elderly will be
assessed.
Background summary
The incidence of venous thrombosis (VT) is one of 100 older people per year
against an incidence of 1-3 per 1000 per year in the general population. The
prevalantce of thrombosis wil increase because an increase of percentage
elderly in the world population in the coming decennia. In the last years
several genetic and environmental riskfactors are described for developing VT,
although until this moment little is known about the specific riskfactors of VT
in the elderly. Futhermore scarce is known about the development of PTS in this
population and the impact of the event on people's quality of life and
mobility.
Study objective
Primary question: What are the riskfacors of VT in the older population?
Secondary questions: What is the frequence and seriousness of the PTS in the
elderly and which impact has the VT on the QOL and the functionality of this
group.
Study design
Case-controle study in which patients recruitment will be done via the
anti-coagulation clinics in Leiden and Haarlem and the controls will be
approached via the LEON, a network of general practicioners.
Two patient-visits will be planned, 1 month and 1 year after the diagnosis to
fill in questionnairs and to obtain a bloodsample. The controls will be invited
for one visit to fill in the questionnaire and for one bloodsample.
Study burden and risks
Patients: two visits of 1 hour, an interview, two times bloodsamples in one
year. Bloodpressure measurement, lenght and weight measurement.
Controls: one visit of 1 hour, an interview, two times bloodsamples in one
year. Bloodpressure measurement, lenght and weight measurement.
Collection of small blood samples is a standard procedure in medical practice.
Therefore, the risk of study participation is expected to be low.
Postbus 9600
2300 RC Leiden
Nederland
Postbus 9600
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
venous thrombotic event (lower extremities and pulmonary embolus)
age 70 and older
Exclusion criteria
active malignancy (palliative phase or cancer-treatment for the last 6 months)
serious cognitive disorder
non-dutch speaker
Design
Recruitment
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL21966.058.08 |