NCT06919341 RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
| NCT ID | NCT06919341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Española de Hematología y Hemoterapía |
| Condition | ITP - Immune Thrombocytopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2034-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-09-27 with a primary completion date of 2034-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary immune thrombocytopenia (PIT), previously referred to as idiopathic thrombocytopenic purpura, is an acquired disease characterized by accelerated platelet destruction and deficient platelet production by megakaryocytes. Although the existence of PIT has been known for decades, there is no consensus on its triggering mechanisms. On the other hand, this disease presents a very heterogeneous patient profile, both in its characteristics and treatments. In this sense, the diagnosis is still made by excluding other causes of thrombocytopenia. There is insufficient epidemiological data on the disease, a fact that is especially evident in our country. We have no data on the incidence or prevalence of this pathology in Spain. For all these reasons, this epidemiological study has been designed to increase the available knowledge about this disease and the detailed characterization of the population of patients with ITP in Spain. The main objective of this study is to describe the clinical, analytical and treatment characteristics of primary immune thrombocytopenia and other immune thrombocytopenia. The study is an epidemiological, ambispective, multicenter study carried out in hospitals in Spain. Information will be collected on the disease under study, as well as on the treatments received, using the patient's clinical history as a source document.
Eligibility Criteria
Inclusion Criteria: * Children as young as 2 months of age and adults in follow-up since 2015 (irrespective of date of diagnosis) with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count \< 100 x 109/L. * Patients who have given written informed consent. In the case of deceased patients, the data will be included in the registry and the investigator will record the impossibility of collecting patient's informed consent form due to death. Only patients deceased after December 31 2015, will be included Exclusion Criteria: * Patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06919341 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, studying ITP - Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919341 currently recruiting?
Yes, NCT06919341 is actively recruiting participants. Contact the research team at sehh@sehh.es for enrollment information.
Where is the NCT06919341 trial being conducted?
This trial is being conducted at A Coruña, Spain, Palma, Spain, Barcelona, Spain, Barcelona, Spain and 11 additional locations.
Who is sponsoring the NCT06919341 clinical trial?
NCT06919341 is sponsored by Fundación Española de Hematología y Hemoterapía. The trial plans to enroll 1,000 participants.