RecruitingNCT06919341

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


Sponsor

Fundación Española de Hematología y Hemoterapía

Enrollment

1,000 participants

Start Date

Sep 27, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 2 Months

Inclusion Criteria2

  • 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 Criteria1

  • Patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study

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Locations(36)

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital Universitario Son Espases

Palma, Balearic Islands, Spain

Hospital Del Mar

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron (

Barcelona, Barcelona, Spain

Hospital Universitario Mutua Terrassa

Terrassa, Barcelona, Spain

Hospital de Basurto

Bilbao, Biskaia, Spain

Hospital Sierrallana

Torrelavega, Cantabria, Spain

Hospital de La Plana

Castellon, Castellón, Spain

Hospital Universitario Punta de Europa

Algeciras, Cádiz, Spain

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Hospital Universitario de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Reina Sofia de Córdoba

Córdoba, Córdoba, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Hospital Juan Ramón Jimenez

Huelva, Huelva, Spain

Complejo Hospitalario de Jaén

Jaén, Jaén, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Universitario Arnau de Vilanova

Lleida, Lérida, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario 12 octubre

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Costa del Sol

Marbella, Málaga, Spain

Hospital Universitario Regional de Málaga

Málaga, Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital materno infantil de Málaga

Málaga, Málaga, Spain

Hospital de la Serranía de Ronda

Ronda, Málaga, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Hospital de la Merced

Osuna, Sevilla, Spain

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, Spain

Hospital Universitario Virgen del Rocio

Seville, Sevilla, Spain

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

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NCT06919341


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