Characterization of platelets and antibodies in adult patients with immune thrombocytopenia (ITP)

Recruiting

• Conditions: immune thrombocytopenia; 10035534; 10003816

• Registration Number: NL-OMON47599
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients receiving corticosteroids, IVIG or TPO receptor agonists are allowed to participate. ;- Age minimal 18 years, both men and women
- Subjects with primary/chronic ITP (as defined by [Rodeghiero] with platelet numbers that have been below <30*10^9/L at one timepoint)
- Written informed consent
- WHO performance status <3

Exclusion Criteria

- Prior treatment with rituximab as this will interfere with B-cell isolation
- Use of anticoagulants (e.g. NSAIDs) affecting platelet function
- Inadequate renal and liver function, i.e. creatinine or bilirubin >2.5 x the upper normal value
- Severe cardiac dysfunction
- Severe pulmonary dysfunction
- Severe neurological or psychiatric disease
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, hypertension, cancer, etc.)
- Neutrophil count <1.5*10^9/L and hemoglobin level <6.2 mmol/L.
- Active bleeding (defined by grade 3 or 4 according to NCI CTCAE v3.0)
- Pregnant or lactating
- Systemic infections: active viral infections, including HIV
- Seriously immunocompromised patients
- Systemic autoimmune disorders (e.g. systemic lupus erythematosus, SLE)
- Current malignant disease
- Any experimental therapy within 30 days prior to blood draw

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>One of the primary results will include platelet properties as described in the<br /><br>study design. Investigation will involve receptor expression on the<br /><br>thrombocytes and functional properties via aggregation tests.<br /><br><br /><br>The other primary result will be the characterization of patient<br /><br>autoantibodies, and successful isolation of mononuclear cells and subsequent<br /><br>selection of platelet-reactive B-cells.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/a</p><br>