To assess platelet function and coagulation parameters in adult chronic ITP patients in relation to their bleeding phenotype
ID
Source
Brief title
Condition
- Platelet disorders
- Autoimmune disorders
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
bleeding phenotype, platelet function, coagulation parameters
Secondary outcome
- To assess immune profiles in chronic ITP patients and explore for imbalances
between effector cells and regulatory cells
- To validate the CIS-20 fatigue subscale in chronic ITP patients by comparing
it to the FACIT-F
- To assess the prevalence of menorrhagia in female chronic IT patients and the
impact on daily life
- To compare fatigue in chronic ITP patients with published data of fatigue in
healthy controls and other chronically ill patients
Background summary
ITP is a heterogeneous autoimmune disease leading to an increased destruction
and decreased production of platelets. The function of platelets is unknown,
but developing techniques make it possible to evaluate this in thrombocytopenic
samples. We aim to assess the relationship between bleeding phenotype and
platelet function. Secondary, we will assess immune profiles in ITP patients
and focus on quality of life factors, in fatigue and in women also menstrual
problems.
Study objective
To assess platelet function and coagulation parameters in adult chronic ITP
patients in relation to their bleeding phenotype
Study design
Non-interventional, non-randomized, non-blinded, observational trial design.
Study burden and risks
For participation of the study a blood sample will be withdrawn If possible,
this blood sample will be taken during a scheduled venipuncture, as part of
standard of care. Otherwise, a separate study visit will be planned. In this
case, the burden associated with study participation is the travelling time and
the extra venipuncture. Travel expenses and parking costs will then be
compensated. The risk associated with venipunctures in ITP patients is
considered low, but formation of a small, local hematoma and pain/discomfort
can occur. The amount of blood that is withdrawn is negligible (32 cc).
The two questionnaires will take approximately 10-15 minutes, the ITP-BAT 10-20
minutes. Women will be asked to fill out an additional questionnaire that takes
3-5 minutes and to keep a chart during one month.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Age 16 years and older
- Previously confirmed diagnosis of chronic primary ITP with current platelet
counts of <100x10^9/L
- Willing and able to understand the study information and sign the informed
consent form.
To be eligible for the subgroup analyses addressing the menorrhagia objective,
a subject
must meet all of the following criteria in addition to the criteria
above:
- Female
- Postmenarcheal but premenopausal
- In possession of a uterus (e.g. no hysterectomy in the past)
Exclusion criteria
None applicable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66313.041.18 |