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NCT Number: NCT06919341

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Description of the clinical and analytical features of PIT and other immune thrombocytopenias.

    Time frame: From enrollment

Secondary outcomes

  1. Comparison with published historical ITP data

    Time frame: From enrollment

  2. Definition of therapeutic strategies and most common treatments in ITP

    Time frame: From enrollment

  3. Evaluation of response to first-line treatment

    Time frame: From enrollment

  4. Evaluation of response to subsequent treatments

    Time frame: From enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda López Picado

CONTACT

[email protected]

646075853

Cristina Pascual Izquierdo, MD

CONTACT

[email protected]

91 586 8445

Sponsors and collaborators

Lead sponsor

Fundación Española de Hematología y Hemoterapía

Other

Registry information

Acronym: RESTI

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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