Registry for patients with Primary Immune Thrombocytopenia in Spain
RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 2 Months and up |
| Sex | All |
| Sponsor | Fundación Española de Hematología y Hemoterapía Academic / other |
| Locations | 36 sites (A Coruña, A Coruña and 35 other locations) |
| Trial ID | NCT06919341 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
A Coruña, A Coruña and 35 other locations
- 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 Vall d'Hebron ( — Barcelona, Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario Mutua Terrassa — Terrassa, Barcelona, Spain (Not_yet_recruiting)
- Hospital de Basurto — Bilbao, Biskaia, Spain (Recruiting)
- Hospital Sierrallana — Torrelavega, Cantabria, Spain (Not_yet_recruiting)
- Hospital de La Plana — Castellon, Castellón, Spain (Recruiting)
- Hospital Universitario Punta de Europa — Algeciras, Cádiz, Spain (Recruiting)
- 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 Universitario Arnau de Vilanova — Lleida, Lérida, Spain (Not_yet_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 La Paz — Madrid, Madrid, Spain (Not_yet_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)
- Complejo Asistencial Universitario de Salamanca — Salamanca, Salamanca, Spain (Not_yet_recruiting)
- Hospital Universitario de Canarias — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital de la Merced — Osuna, Sevilla, Spain (Not_yet_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)
Study contacts
- Study coordinator: Cristina Pascual Izquierdo, MD
- Email: sehh@sehh.es
- Phone: 91 586 8445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.