RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorFundación Española de Hematología y Hemoterapía
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study
Trial population
People with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count \< 100 x 109/L.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Description of the clinical and analytical features of PIT and other immune thrombocytopenias.
Time frame
From enrollmentSecondary outcomes
1
Comparison with published historical ITP data
Time frame
From enrollment2
Definition of therapeutic strategies and most common treatments in ITP
Time frame
From enrollment3
Evaluation of response to first-line treatment
Time frame
From enrollment4
Evaluation of response to subsequent treatments
Time frame
From enrollmentSponsors and contacts
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Source ClinicalTrials.gov