Clinical trial NCT06919341: RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
Official title: RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ITP - Immune Thrombocytopenia
Primary Immune Thrombocytopenia (ITP)
Keywords: ITP
PTI
Trombocitopenia inmune primaria
Primary Inmune Thrombocytopenia
Lead sponsor: Fundación Española de Hematología y Hemoterapía
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count \< 100 x 109/L.

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

Primary outcomes:
measure: Description of the clinical and analytical features of PIT and other immune thrombocytopenias.
timeFrame: From enrollment
Secondary outcomes:
measure: Comparison with published historical ITP data
timeFrame: From enrollment
measure: Definition of therapeutic strategies and most common treatments in ITP
timeFrame: From enrollment
measure: Evaluation of response to first-line treatment
timeFrame: From enrollment
measure: Evaluation of response to subsequent treatments
timeFrame: From enrollment
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua Terrassa
state: Barcelona
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Biskaia
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
state: Cantabria
city: Algeciras
country: Spain
facility: Hospital Universitario Punta de Europa
state: Cádiz
city: Jerez de la Frontera
country: Spain
facility: Hospital Universitario de Jerez
state: Cádiz
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
state: Lérida
city: Marbella
country: Spain
facility: Hospital Universitario Costa del Sol
state: Málaga
city: Ronda
country: Spain
facility: Hospital de la Serranía de Ronda
state: Málaga
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Osuna
country: Spain
facility: Hospital de la Merced
state: Sevilla
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron (
city: Castellón
country: Spain
facility: Hospital de La Plana
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia de Córdoba
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jimenez
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital materno infantil de Málaga
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: