About this trial
REPTT is an observational, prospective, multi-country, multicentre and non-interventional registry in which at least 300 patients with Thrombotic thrombocytopenic purpura (TTP) in Spain and Portugal will be evaluated.
The study will be carried out in the context of the usual clinical practice conditions, not imposing restrictions on the participating physician or influencing their normal clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with diagnosis of TTP according to International Consensus criteria from centres in Spain and Portugal.
Patients that voluntarily sign the informed consent. For subjects unable to provide informed consent, a fully recognized medical authority may be used according to local laws.
Patients between 0 to 99 years old at the time of diagnosis.
Disqualifiers
Inability to comply with study procedures and follow-up exams.
Patients with any type of alteration that compromises their ability to grant written informed consent.
Patients that do not consent to participate in the study and do not sign informed consent.
Patients that do not meet the criteria previously mentioned for TTP.
Trial population
Patients diagnosed with Thrombotic thrombocytopenic purpura (TTP)
Trial design
Cohort
Prospective
Treatments tested in this trial
Standard clinical practice
Other interventionThe study will be carried out in the context of the usual clinical practice conditions, not imposing restrictions on the participating physician or influencing their normal clinical practice.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of TTP in Spain/Portugal
Number of patients diagnosed with TTP and enrolled in the registry per year
Morbidity of TTP in Spain/Portugal
Percentage of patients diagnosed with TTP and enrolled in the registry among spanish / portuguese population per year
Mortality of TTP in Spain/Portugal
Percentage of patients diagnosed with TTP and enrolled in the registry per year who died due to the disease
Secondary outcomes
Clinical response to treatment rate
Defined as sustained normalization of platelet counts above the lower limit of the established reference range and of lactate dehydrogenase (LDH) after cessation of plasma exchange. The number of patients that achieved clinical response and their frequency will be reported.
TTP Clinical remission rate
Defined as a clinical response after cessation of plasma exchange, maintained for \> 30 days. The number of patients that achieved clinical remission and their frequency will be reported
TTP Exacerbation rate
Defined as a reduction in platelet count to below the lower limit of the established reference range, an increased LDH level, and the need to restart plasma exchange within 30 days of the last plasma exchange after a clinical response to plasma exchange. The number of patients with exacerbations and their frequency will be reported
TTP Relapse rate
Defined as a fall in platelet count to below the lower limit of the established reference range, with or without clinical symptoms, \> 30 days after stopping of plasma exchange for an acute TTP episode, requiring reinitiation of therapy. This is usually associated with a new increase in the LDH level. The number of patients with relapse and their frequency will be reported.
Sponsors and contacts
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