MedDataX Logo

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

NCT ID: NCT06919341

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-27

Study Completion Date

2034-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The International ITP Registry

NCT01970189

Thrombocytopenia
UNKNOWN

Longitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP)

NCT06107582

Primary Immune Thrombocytopenia
RECRUITING

Spanish-Portuguese Thrombotic Thrombocytopenic Purpura Registry

NCT05914441

Purpura, Thrombocytopenic
RECRUITING

Observatory of Immunological Thrombopenic Purpura in the Brest Region

NCT06556888

Immune Thrombocytopenia
RECRUITING

Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

NCT01571349

Idiopathic Thrombocytopenic Purpura
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ITP - Immune Thrombocytopenia Primary Immune Thrombocytopenia (ITP)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundación Española de Hematología y Hemoterapía

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Site Status RECRUITING

Hospital Universitario Son Espases

Palma, Balearic Islands, Spain

Site Status RECRUITING

Hospital Del Mar

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Vall d'Hebron (

Barcelona, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Mutua Terrassa

Terrassa, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital de Basurto

Bilbao, Biskaia, Spain

Site Status RECRUITING

Hospital Sierrallana

Torrelavega, Cantabria, Spain

Site Status NOT_YET_RECRUITING

Hospital de La Plana

Castellon, Castellón, Spain

Site Status RECRUITING

Hospital Universitario Punta de Europa

Algeciras, Cádiz, Spain

Site Status RECRUITING

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Site Status RECRUITING

Hospital Universitario de Jerez

Jerez de la Frontera, Cádiz, Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia de Córdoba

Córdoba, Córdoba, Spain

Site Status RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status RECRUITING

Hospital Juan Ramón Jimenez

Huelva, Huelva, Spain

Site Status RECRUITING

Complejo Hospitalario de Jaén

Jaén, Jaén, Spain

Site Status RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Site Status RECRUITING

Hospital Universitario Arnau de Vilanova

Lleida, Lérida, Spain

Site Status NOT_YET_RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario 12 octubre

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Costa del Sol

Marbella, Málaga, Spain

Site Status RECRUITING

Hospital Universitario Regional de Málaga

Málaga, Málaga, Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Site Status RECRUITING

Hospital materno infantil de Málaga

Málaga, Málaga, Spain

Site Status RECRUITING

Hospital de la Serranía de Ronda

Ronda, Málaga, Spain

Site Status RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, Salamanca, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Site Status RECRUITING

Hospital de la Merced

Osuna, Sevilla, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Sevilla, Spain

Site Status RECRUITING

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristina Pascual Izquierdo, MD

Role: CONTACT

[email protected]
91 586 8445

Amanda López Picado

Role: CONTACT

[email protected]
646075853

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

María del Carmen Gómez Del Castillo Solano, MD

Role: primary

[email protected]
034 + 981 17 80 00

Mariana Canaro, MD

Role: primary

[email protected]
034 + 871 20 50 00

Blanca Sánchez González, MD

Role: primary

[email protected]
034 + 93 248 30 00

David Valcárcel Ferreiras

Role: primary

[email protected]
034 + 934 89 30 00

Silvia Del Rocio Verdesoto Cozzarelli, MD

Role: primary

[email protected]
034 + 937 36 50 50

Laura Hernández Vázquez

Role: primary

[email protected]
034 + 944 00 60 00

Amalia Cuesta García

Role: primary

[email protected]
034+ 942 84 74 00

Silvia Bernat Pablo

Role: primary

[email protected]
034 + 964399775

Alberto Casaus Garcia, MD

Role: primary

[email protected]
034+ 956 02 50 00

María Yera Cobo, MD

Role: primary

[email protected]
034 + 956 00 21 00

Rosa María Campos Álvarez, MD

Role: primary

[email protected]
034+ 956 03 20 00

Mª Carmen Fernandez Sanchez de Mora, MD

Role: primary

[email protected]
034+ 957 01 00 00

Laura Entrena Ureña, MD

Role: primary

[email protected]
034+ 958 02 00 00

Bianca Dí-az Roldan, MD

Role: primary

[email protected]
034+ 959 01 60 00

María Nieto Hernández, MD

Role: primary

[email protected]
034+ 953 00 80 00

Alvaro Lorenzo Vizcaya, MD

Role: primary

[email protected]
034 + 982 29 60 00

Armando Galán, MD

Role: primary

[email protected]
034 + 973 24 81 00

Elena Sebastián Pérez, MD

Role: primary

[email protected]
915 03 59 00

Estefanía Bolaños Calderón

Role: primary

[email protected]
034+ 913 30 30 00

Cristina Pascual Izquierdo, MD

Role: primary

[email protected]
034+ 913191998

Denis Zafra Torres, MD

Role: primary

[email protected]
034 + 913 90 80 00

Mª Teresa Álvarez Román, MD

Role: primary

[email protected]
034 + 917 27 70 00

Mª Esperanza Moreno Beltrán, MD

Role: primary

[email protected]
034 + 951 97 66 69

Francisco José López Jaime, MD

Role: primary

[email protected]
034+ 951 29 00 00

Isabel Socorro Caparrós Miranda, MD

Role: primary

[email protected]
034 + 951 03 20 00

Mª Rosario Prieto Bonilla, MD

Role: primary

[email protected]
034+ 951 29 00 00

Reyes Jiménez Bárcenas, MD

Role: primary

[email protected]
034 + 951 06 50 00

Montse Alvarellos Outeiro, MD

Role: primary

[email protected]
034 + 848 42 22 22

Daniel Martínez Carballeira, MD

Role: primary

[email protected]
034+ 985 10 80 00

José María Bastida Bermejo

Role: primary

[email protected]
034+ 923 29 11 00

Sunil Lakhwani

Role: primary

[email protected]
034 + 922 67 80 00

Rocío Cardesa Cabrera

Role: primary

[email protected]
034 + 955 07 72 00

Gloria García-Donas Gabaldón, MD

Role: primary

[email protected]
0340 + 955 00 80 00

MARIA EVA MINGOT CASTELLANO, MD

Role: primary

[email protected]
034+ 955 01 20 00

Marisa Calabuig Muñoz

Role: primary

[email protected]
034 + 961 97 35 00

Gonzalo Caballero Navarro, MD

Role: primary

[email protected]
034+ 976 76 55 00

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RESTI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Longitudinal Observational Study on Immune Thrombocytopenia
NCT07068425 NOT_YET_RECRUITING
Steroid Resistance in Pediatric Immune Thrombocytopenic Purpura
NCT06601543 NOT_YET_RECRUITING
Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe
NCT06408324 COMPLETED
Study of Immune Thrombocytopenia Pathogenesis:
NCT02042560 COMPLETED
Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)
NCT01510873 COMPLETED
National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients
NCT07268898 NOT_YET_RECRUITING
Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010
NCT06466824 NOT_YET_RECRUITING
Investigation on a Dynamic Cohort of Italian Patients With Active ITP
NCT03465020 UNKNOWN
Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim
NCT01439321 COMPLETED
Risk Factors for Thrombosis in Immune Thrombocytopenia
NCT03820960 COMPLETED
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
NCT01525836 COMPLETED PHASE3
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
NCT06658834 RECRUITING PHASE2
Diagnostic Characterization and Evolution of "Triple Negative" Thrombocytosis (CASTETTE)
NCT06481332 ACTIVE_NOT_RECRUITING
The Outcome of the Thrombopoietin Receptor Agonists in Pediatric Patient With Persistent or Chronic ITP Unresonsive to Steroids
NCT06568913 RECRUITING NA
Italian Study for Congenital Platelet Disorders
NCT06691581 ACTIVE_NOT_RECRUITING
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
NCT01143038 COMPLETED PHASE2
Role of ROTEM and Platelet Indices in Thrombocytopenic Patients .
NCT05850481 UNKNOWN
A Multicentre Investigation of 2 Cycles Rituximab Compared With Standard Regimen in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
NCT02137681 WITHDRAWN PHASE3
Value of Platelet Indices as Predictive Factor in Thrombocytopenia
NCT05116033 UNKNOWN
Rituximab as Second Line Treatment for ITP
NCT00344149 COMPLETED PHASE3
Lymphocyte Counts in Immune Thrombocytopenic Purpura
NCT03244410 UNKNOWN
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
NCT01933035 COMPLETED
Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura
NCT04056507 COMPLETED
Bleeding Prediction in Thrombocytopenia
NCT02306044 COMPLETED
Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura
NCT00486421 COMPLETED EARLY_PHASE1