To study the effect of different treatment modalities, in newly diagnosed ITP patients, on disease activity, platelet activity, the results of the MAIPA, and the relation between these.
ID
Source
Brief title
Condition
- Platelet disorders
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Platelet activity, according to the PATS (P10.127) test and platelet
auto-antibodies according to the MAIPA (P12.106).
Secondary outcome
na
Background summary
We previous started a study designed to validate a platelet activity test for
use in hemato-oncology patients who are thrombocytopenic due to
myelo-suppressive or ablative treatments, the *Platelet Activity Test
Study* (PATS; P10.127). In this study we included a small sample of ITP
patients as a control group. In these ITP patients we observed three distinct
groups; exhibiting low, normal and high platelet activity. These, however, were
all prevalent patients with widely divergent treatment histories. We now
hypothesize previously received treatments could have influenced platelet
activity. Higher platelet activity might partly compensate for lower platelet
numbers in ITP. Therefore, it is relevant to know the effect of treatment on
activity as well as on the number of platelet.
Also, previously, we performed the *Validation of the monoclonal antibody
immobilization of platelet antigen (MAIPA) assay to show autoantibodies against
thrombocytes* (P12.106). This study evaluated the diagnostic significance of
the MAIPA, but this test could also be used to monitor the effect of treatment.
Study objective
To study the effect of different treatment modalities, in newly diagnosed ITP
patients, on disease activity, platelet activity, the results of the MAIPA, and
the relation between these.
Study design
Cohort.
Study burden and risks
Minimal to negligible. Only 37 mL of additional blood drawn per time point.
Plesmanlaan 1a
Leiden 2333BZ
NL
Plesmanlaan 1a
Leiden 2333BZ
NL
Listed location countries
Age
Inclusion criteria
newly diagnosed, untreated ITP
Exclusion criteria
anders
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 | NL44265.058.13 |