Recent data shows that patients with ITP have increased levels of the so called platelet-extracellular-vesicles (EVs). In this pilotstudy we would like to characterize these EVs and investigate whether they play a pathogenic role in the maintenance…
ID
Source
Brief title
Condition
- Platelet disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentration of EVs in ITP patients; Wilcoxon signed rank tests will be used
to compare EV concentrations between groups. Of interest are EVs derived from
platelets (CD61+), activated platelets (CD62p+) and erytrocytes (CD235a+).
Secondary outcome
Association of (platelet-derived) EVs with age, sex and current/past therapy.
Background summary
Primary Immune Thrombocytopenia (ITP) is an acquired isolated trombocytopenia
(platelet count < 100 x 109/l) without an underlying disease or cause of the
thrombocytopenia. ITP can occur due to increased platelet clearance medicated
by autoantibodies, decreased platelet production and T-cell mediated processes.
The incidence of ITP is approximately 50/1.000.000. The prevalence is equally
distributed between male and female, except for the age category 30-60 years
where the prevalence of ITP is higher in female. ITP is classified according
the duration of the disease: acute ITP, persistent ITP (3-12 months) and
chronic ITP (>12 months). Most important symptoms are bleeding and decreased
health related quality of life. Clinical symptoms may vary between none to life
threatening bleedings. Most bleeding symptoms occur with a platelet count
<30x109/L although there is no relationship between platelet count and bleeding
severity.
Due to the large heterogeneity between patients it is difficult to predict
disease severity and therapy response. A better understanding of the underlying
pathology is most important to improve patient care.
r
Study objective
Recent data shows that patients with ITP have increased levels of the so called
platelet-extracellular-vesicles (EVs). In this pilotstudy we would like to
characterize these EVs and investigate whether they play a pathogenic role in
the maintenance of ITP. Also we would like to measure the association with
therapy response.
Study design
single center observational pilotstudy. Test will be performed at Sanquin
Amsterdam and patients will be recruited at Erasmus MC.
Study burden and risks
The burden for ITP patients is one blood draw during routine clinical test. The
amount of blood is 9mL in total (One 3mL EDTA tube and two 3mL citrate tubes).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Adult patients with ITP
Informed consent will be obtained
Exclusion criteria
Patients with secondary ITP
Patients with antiplatelet therapy
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 | NL87357.078.24 |