Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP) (NCT06665308) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
United States, United Kingdom97 participantsStarted 2025-01-13
Plain-language summary
This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results. The study will include adult patients with chronic (\> 1 year duration) primary Immune Thrombocytopenia (ITP) only. Patients will be identified based on a laboratory confirmed diagnosis of ITP in the medical records, where there is also a physician-confirmed diagnosis of primary ITP. If patients consent to take part in the study, a routine clinical visit will also serve as the study visit. Patients who do not have a routine visit scheduled during the study period but who would otherwise be eligible may be contacted by the site. In such cases, clinicians may use their discretion to schedule a visit specifically for study purposes.
All study participants will have a routine blood test as part of their standard clinical care at the study visit, and this same procedure will be used to collect supplementary blood samples to assess a variety of biomarkers.
Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient diagnosed with chronic (ITP with \> 1 year duration) primary ITP living in the USA or the UK:
* On ITP pharmacologic treatment, , including on-demand treatment strategy, regardless of last platelet count (below or above 100 x 10\^9 counts/L);
* Patients with their most recent platelet count \>50 x 109 counts/L) and without any ITP-specific treatment for 1 year or less.
* Adult patient who are 18 years or older at index date
* Patient who has received at least one initial first line ITP therapy (CS/ IVIg/ANTI d) with initial response as of index date and indicated by one of the following:
* Platelet count ≥ 50 x 10\^9 counts /L; OR
* Platelet count ≥ 30 x 10\^9 counts /L with at least a two-fold increase from baseline within 1 month since start of treatment, as per ASH 2019 guidelines; OR
* A medical record of initial response as determined by clinical judgement, considering documented platelet count along with overall patient condition and relevant medical factors.
* Patients whose medical history related to the study objectives are available from the site covering 12 months prior to index date.
* Patient provided informed consent to participate in the study.
Exclusion Criteria:
* Secondary ITP.
* Patients with their most recent platelet count \>50 x 10\^9 counts/L and without any ITP-specific treatment for more than 1 year.
* Patients with recent or active infection recorded 14 days or less before index date; patients with uncontr…
What they're measuring
1
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients