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

April 7, 2025 updated by: Fundación Española de Hematología y Hemoterapía

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cristina Pascual Izquierdo, MD
  • Phone Number: 91 586 8445
  • Email: sehh@sehh.es

Study Contact Backup

  • Name: Amanda López Picado
  • Phone Number: 646075853
  • Email: sehh@sehh.es

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complexo Hospitalario Universitario A Coruña
        • Contact:
          • María del Carmen Gómez Del Castillo Solano, MD
          • Phone Number: 034 + 981 17 80 00
          • Email: sehh@sehh.es
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Blanca Sánchez González, MD
          • Phone Number: 034 + 93 248 30 00
          • Email: sehh@sehh.es
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Vall d'Hebron (
        • Contact:
          • David Valcárcel Ferreiras
          • Phone Number: 034 + 934 89 30 00
          • Email: sehh@sehh.es
      • Castellón, Spain, 12540
        • Recruiting
        • Hospital de La Plana
        • Contact:
          • Silvia Bernat Pablo
          • Phone Number: 034 + 964399775
          • Email: sehh@sehh.es
      • Cádiz, Spain, 11009
        • Recruiting
        • Hospital Puerta del Mar
        • Contact:
          • María Yera Cobo, MD
          • Phone Number: 034 + 956 00 21 00
          • Email: sehh@sehh.es
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofía de Córdoba
        • Contact:
          • Mª Carmen Fernandez Sanchez de Mora, MD
          • Phone Number: 034+ 957 01 00 00
          • Email: sehh@sehh.es
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
          • Laura Entrena Ureña, MD
          • Phone Number: 034+ 958 02 00 00
          • Email: sehh@sehh.es
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Juan Ramón Jimenez
        • Contact:
          • Bianca Dí-az Roldan, MD
          • Phone Number: 034+ 959 01 60 00
          • Email: sehh@sehh.es
      • Jaén, Spain, 23007
        • Recruiting
        • Complejo Hospitalario de Jaén
        • Contact:
          • María Nieto Hernández, MD
          • Phone Number: 034+ 953 00 80 00
          • Email: sehh@sehh.es
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Alvaro Lorenzo Vizcaya, MD
          • Phone Number: 034 + 982 29 60 00
          • Email: sehh@sehh.es
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Estefanía Bolaños Calderón
          • Phone Number: 034+ 913 30 30 00
          • Email: sehh@sehh.es
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Nino Jesus
        • Contact:
          • Elena Sebastián Pérez, MD
          • Phone Number: 915 03 59 00
          • Email: sehh@sehh.es
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 Octubre
        • Contact:
          • Denis Zafra Torres, MD
          • Phone Number: 034 + 913 90 80 00
          • Email: sehh@sehh.es
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Mª Teresa Álvarez Román, MD
          • Phone Number: 034 + 917 27 70 00
          • Email: sehh@sehh.es
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
          • Cristina Pascual Izquierdo, MD
          • Phone Number: 034+ 913191998
          • Email: sehh@sehh.es
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Isabel Socorro Caparrós Miranda, MD
          • Phone Number: 034 + 951 03 20 00
          • Email: sehh@sehh.es
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Regional de Malaga
        • Contact:
          • Francisco José López Jaime, MD
          • Phone Number: 034+ 951 29 00 00
          • Email: sehh@sehh.es
      • Málaga, Spain, 29011
        • Recruiting
        • Hospital Materno Infantil de Málaga
        • Contact:
          • Mª Rosario Prieto Bonilla, MD
          • Phone Number: 034+ 951 29 00 00
          • Email: sehh@sehh.es
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Complejo Asistencial Universitario de Salamanca
        • Contact:
          • José María Bastida Bermejo
          • Phone Number: 034+ 923 29 11 00
          • Email: sehh@sehh.es
      • Santa Cruz de Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • Sunil Lakhwani
          • Phone Number: 034 + 922 67 80 00
          • Email: sehh@sehh.es
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • MARIA EVA MINGOT CASTELLANO, MD
          • Phone Number: 034+ 955 01 20 00
          • Email: sehh@sehh.es
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen de la Macarena
        • Contact:
          • Gloria García-Donas Gabaldón, MD
          • Phone Number: 0340 + 955 00 80 00
          • Email: sehh@sehh.es
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico de Valencia
        • Contact:
          • Marisa Calabuig Muñoz
          • Phone Number: 034 + 961 97 35 00
          • Email: sehh@sehh.es
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Gonzalo Caballero Navarro, MD
          • Phone Number: 034+ 976 76 55 00
          • Email: sehh@sehh.es
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Daniel Martínez Carballeira, MD
          • Phone Number: 034+ 985 10 80 00
          • Email: sehh@sehh.es
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Not yet recruiting
        • Hospital Universitario Mútua Terrassa
        • Contact:
          • Silvia Del Rocio Verdesoto Cozzarelli, MD
          • Phone Number: 034 + 937 36 50 50
          • Email: sehh@sehh.es
    • Biskaia
      • Bilbao, Biskaia, Spain, 48013
        • Recruiting
        • Hospital de Basurto
        • Contact:
          • Laura Hernández Vázquez
          • Phone Number: 034 + 944 00 60 00
          • Email: sehh@sehh.es
    • Cantabria
      • Torrelavega, Cantabria, Spain, 39300
        • Not yet recruiting
        • Hospital Sierrallana
        • Contact:
          • Amalia Cuesta García
          • Phone Number: 034+ 942 84 74 00
          • Email: sehh@sehh.es
    • Cádiz
      • Algeciras, Cádiz, Spain, 11207
        • Recruiting
        • Hospital Universitario Punta de Europa
        • Contact:
          • Alberto Casaus Garcia, MD
          • Phone Number: 034+ 956 02 50 00
          • Email: sehh@sehh.es
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Recruiting
        • Hospital Universitario de Jerez
        • Contact:
          • Rosa María Campos Álvarez, MD
          • Phone Number: 034+ 956 03 20 00
          • Email: sehh@sehh.es
    • Islas Baleares
      • Palma, Islas Baleares, Spain, 07120
        • Recruiting
        • Hospital Universitario Son Espases
        • Contact:
          • Mariana Canaro, MD
          • Phone Number: 034 + 871 20 50 00
          • Email: sehh@sehh.es
    • Lérida
      • Lleida, Lérida, Spain, 25198
        • Not yet recruiting
        • Hospital Universitario Arnau de Vilanova
        • Contact:
          • Armando Galán, MD
          • Phone Number: 034 + 973 24 81 00
          • Email: sehh@sehh.es
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Recruiting
        • Hospital Universitario Costa del Sol
        • Contact:
          • Mª Esperanza Moreno Beltrán, MD
          • Phone Number: 034 + 951 97 66 69
          • Email: sehh@sehh.es
      • Ronda, Málaga, Spain, 29400
        • Recruiting
        • Hospital de la Serranía de Ronda
        • Contact:
          • Reyes Jiménez Bárcenas, MD
          • Phone Number: 034 + 951 06 50 00
          • Email: sehh@sehh.es
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
          • Montse Alvarellos Outeiro, MD
          • Phone Number: 034 + 848 42 22 22
          • Email: sehh@sehh.es
    • Sevilla
      • Osuna, Sevilla, Spain, 41640
        • Not yet recruiting
        • Hospital de la Merced
        • Contact:
          • Rocío Cardesa Cabrera
          • Phone Number: 034 + 955 07 72 00
          • Email: sehh@sehh.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of the clinical and analytical features of PIT and other immune thrombocytopenias.
Time Frame: From enrollment
From enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Española de Hematología y Hemoterapía

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

September 1, 2034

Study Completion (Estimated)

September 1, 2034

Study Registration Dates

First Submitted

March 29, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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