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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients