D69.3
Conditions
Interventions
Group 1: ITP Cohort: The determination of platelet phenotypes by flow cytometry at the first visit and then every six months upto 2 years. Clinical data such as treatment response, bleeding score and
Sponsors
Institute für klinische und experimentelle Medizin, Uniklinikum und medizinische Fakültät Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of ITP according to established diagnostic criteria. Willingness to voluntarily participate in the study and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding. Active infectious diseases or other serious medical conditions that could jeopardise participation in the study. Presence of other haematological disorders that could affect the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the proportion of procoagulant platelets over 24 months and its relationship to bleeding severity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of clinically relevant bleeding (ITP-BAT grade = 2) per 100 patient-years during follow-up. 2. Incidence of arterial or venous thrombotic events confirmed by imaging or objective laboratory criteria during the 24-month follow-up. 3. Correlation between baseline procoagulant platelet percentage and first thrombotic event (Cox regression). 4. Between-group comparison of baseline procoagulant platelet percentage and mean fluorescence intensity (MFI) between ITP patients and disease-controls with non-ITP thrombocytopenia. | — |
Countries
Germany
Contacts
Public ContactGünalp Uzun
Insitute für klinische und experimentelle Transfusionsmedizin, Uniklinikum Tübingen
Outcome results
None listed