RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia

Recruiting

• Conditions: ITP - Immune Thrombocytopenia; Primary Immune Thrombocytopenia (ITP)

• Registration Number: NCT06919341
• Lead Sponsor: Fundación Española de Hematología y Hemoterapía

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-27
• Status Verified: 2025-03
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2034-09
• Study Completion: 2034-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the clinical and analytical features of PIT and other immune thrombocytopenias.	From enrollment

Secondary Outcome Measures

Name	Time	Method
Comparison with published historical ITP data	From enrollment
Definition of therapeutic strategies and most common treatments in ITP	From enrollment
Evaluation of response to first-line treatment	From enrollment
Evaluation of response to subsequent treatments	From enrollment

Trial Locations

Locations (36)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Universitario Mutua Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Biskaia, Spain

Hospital Sierrallana; 🇪🇸 Torrelavega, Cantabria, Spain

Hospital Universitario Punta de Europa; 🇪🇸 Algeciras, Cádiz, Spain

Hospital Universitario de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma, Islas Baleares, Spain

Hospital Universitario Arnau de Vilanova; 🇪🇸 Lleida, Lérida, Spain

Hospital Universitario Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital de la Serranía de Ronda; 🇪🇸 Ronda, Málaga, Spain

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital de la Merced; 🇪🇸 Osuna, Sevilla, Spain

Complexo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron (; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital de La Plana; 🇪🇸 Castellón, Spain

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital Universitario Reina Sofia de Córdoba; 🇪🇸 Córdoba, Spain

Hospital Juan Ramón Jimenez; 🇪🇸 Huelva, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Infantil Universitario Niño Jesús; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario 12 octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Regional de Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital materno infantil de Málaga; 🇪🇸 Málaga, Spain

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain