Cross-sectional study for evaluation of Platelet function and Immune profile in patients with Chronic ITP
Completed
- Conditions
- immune thrombocytopenia100355341000381610013326
- Registration Number
- NL-OMON52965
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 97
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>bleeding phenotype, platelet function, coagulation parameters</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess immune profiles in chronic ITP patients and explore for imbalances<br /><br>between effector cells and regulatory cells<br /><br>- To validate the CIS-20 fatigue subscale in chronic ITP patients by comparing<br /><br>it to the FACIT-F<br /><br>- To assess the prevalence of menorrhagia in female chronic IT patients and the<br /><br>impact on daily life<br /><br>- To compare fatigue in chronic ITP patients with published data of fatigue in<br /><br>healthy controls and other chronically ill patients </p><br>