Registry for patients with Primary Immune Thrombocytopenia in Spain
Official title: RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
Run by Fundación Española de Hematología y Hemoterapía · NCT06919341 · Data updated 2026-11-12
This study is collecting information from patients with Primary Immune Thrombocytopenia in Spain to better understand the condition and improve how it's treated.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Months and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Fundación Española de Hematología y Hemoterapía Academic / other |
| Locations | 36 sites (A Coruña, A Coruña and 35 other locations) |
| Status | Recruiting |
| Started | September 27, 2024 |
| Main results expected | September 2034 |
| Study ends | September 2034 |
| Registry record updated | April 9, 2025 |
| Trial ID | NCT06919341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children as young as 2 months and adults diagnosed with PIT or other immune-related thrombocytopenias with a platelet count below 100 x 10^9/L.
✕Probably not a fit
Patients who do not meet the inclusion criteria or those with thrombocytopenia of non-immune origin may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry aims to gather comprehensive epidemiological data on Primary Immune Thrombocytopenia (PIT) and other immune-related thrombocytopenias in Spain. It will include patients of all ages who have been diagnosed with PIT or similar conditions, focusing on their clinical characteristics and treatment histories. The study seeks to enhance understanding of the disease's prevalence and incidence, which is currently lacking in the region. By collecting data from various hospitals, the registry will help characterize the patient population and improve future management strategies.
Why it matters
Potential benefit: If successful, this registry could lead to improved diagnosis and treatment options for patients with Primary Immune Thrombocytopenia.
How similar studies have gone: While there is limited data on similar registries, the approach of collecting epidemiological data on PIT is essential and has shown promise in other regions.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain Recruiting -
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain Recruiting -
Hospital Del Mar
Barcelona, Barcelona, Spain Recruiting -
Hospital de Basurto
Bilbao, Biskaia, Spain Recruiting -
Hospital de La Plana
Castellon, Castellón, Spain Recruiting -
Hospital Universitario Punta de Europa
Algeciras, Cádiz, Spain Recruiting
Show 30 more locations
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Hospital Puerta del Mar
Cadiz, Cádiz, Spain Recruiting -
Hospital Universitario de Jerez
Jerez de la Frontera, Cádiz, Spain Recruiting -
Hospital Universitario Reina Sofia de Córdoba
Córdoba, Córdoba, Spain Recruiting -
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain Recruiting -
Hospital Juan Ramón Jimenez
Huelva, Huelva, Spain Recruiting -
Complejo Hospitalario de Jaén
Jaén, Jaén, Spain Recruiting -
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain Recruiting -
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Spain Recruiting -
Hospital Clínico San Carlos
Madrid, Madrid, Spain Recruiting -
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain Recruiting -
Hospital Universitario 12 octubre
Madrid, Madrid, Spain Recruiting -
Hospital Universitario Costa del Sol
Marbella, Málaga, Spain Recruiting -
Hospital Universitario Regional de Málaga
Málaga, Málaga, Spain Recruiting -
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain Recruiting -
Hospital materno infantil de Málaga
Málaga, Málaga, Spain Recruiting -
Hospital de la Serranía de Ronda
Ronda, Málaga, Spain Recruiting -
Hospital Universitario de Navarra
Pamplona, Navarre, Spain Recruiting -
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain Recruiting -
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain Recruiting -
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, Spain Recruiting -
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain Recruiting -
Hospital Clínico de Valencia
Valencia, Valencia, Spain Recruiting -
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain Recruiting -
Hospital Vall d'Hebron (
Barcelona, Barcelona, Spain Not yet recruiting -
Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, Spain Not yet recruiting -
Hospital Sierrallana
Torrelavega, Cantabria, Spain Not yet recruiting -
Hospital Universitario Arnau de Vilanova
Lleida, Lérida, Spain Not yet recruiting -
Hospital Universitario La Paz
Madrid, Madrid, Spain Not yet recruiting -
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, Spain Not yet recruiting -
Hospital de la Merced
Osuna, Sevilla, Spain Not yet recruiting
Study contacts
- Study coordinator: Cristina Pascual Izquierdo, MD
- Email: sehh@sehh.es
- Phone: 91 586 8445
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Multi-target drugs sequentially combine therapy in adults with newly diagnosed immune thrombocytopenia
This study tests whether starting with standard steroids plus a TPO-RA, then adding a second targeted therapy if needed, can improve platelet counts in adults with newly diagnosed ITP.
-
High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP
This trial tests whether adding orelabrutinib to high-dose dexamethasone helps adults newly diagnosed with primary ITP raise and maintain their platelet counts compared with placebo.
-
CTX112 (zugo-cel) for relapsed/refractory ITP and wAIHA in adults
This trial tests CTX112, an off-the-shelf CD19 CAR-T therapy, to see if it can help adults with relapsed or refractory ITP or wAIHA.
-
Ianalumab plus a thrombopoietin receptor agonist for adults with ITP or Evans syndrome
This study will test whether adding ianalumab to a doctor's chosen TPO-RA is tolerable for adults with immune thrombocytopenia (and an exploratory group with Evans syndrome) who have had prior treatments and are on a stable TPO-RA dose.
-
Intravenous immunoglobulin (5%) treatment for primary immune thrombocytopenia
This study tests whether 5% intravenous immunoglobulin given daily for five days safely raises platelet counts in adults (18–65) with chronic primary ITP and platelet counts below 30 × 10^9/L.
-
Efgartigimod IV for adolescents (12–17) with chronic immune thrombocytopenia
This trial will try intravenous efgartigimod to see if it safely raises platelet counts in people aged 12 to 17 with chronic ITP.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.