RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
RESTI
1 other identifier
observational
1,000
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2024
CompletedFirst Submitted
Initial submission to the registry
March 29, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2034
April 9, 2025
March 1, 2025
9.9 years
March 29, 2025
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of the clinical and analytical features of PIT and other immune thrombocytopenias.
From enrollment
Secondary Outcomes (4)
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
Eligibility Criteria
People with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count \< 100 x 109/L.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006, Spain
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120, Spain
Hospital Del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Vall d'Hebron (
Barcelona, Barcelona, 08035, Spain
Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital de Basurto
Bilbao, Biskaia, 48013, Spain
Hospital Sierrallana
Torrelavega, Cantabria, 39300, Spain
Hospital de La Plana
Castellon, Castellón, 12540, Spain
Hospital Universitario Punta de Europa
Algeciras, Cádiz, 11207, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, 11009, Spain
Hospital Universitario de Jerez
Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Universitario Reina Sofia de Córdoba
Córdoba, Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014, Spain
Hospital Juan Ramón Jimenez
Huelva, Huelva, 21005, Spain
Complejo Hospitalario de Jaén
Jaén, Jaén, 23007, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Lérida, 25198, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28040, Spain
Hospital Universitario 12 octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Universitario Costa del Sol
Marbella, Málaga, 29603, Spain
Hospital Universitario Regional de Málaga
Málaga, Málaga, 29010, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital materno infantil de Málaga
Málaga, Málaga, 29011, Spain
Hospital de la Serranía de Ronda
Ronda, Málaga, 29400, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, 37007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain
Hospital de la Merced
Osuna, Sevilla, 41640, Spain
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013, Spain
Hospital Clínico de Valencia
Valencia, Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2025
First Posted
April 9, 2025
Study Start
September 27, 2024
Primary Completion (Estimated)
September 1, 2034
Study Completion (Estimated)
September 1, 2034
Last Updated
April 9, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share