Spanish-Portuguese Thrombotic Thrombocytopenic Purpura Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 99
SponsorFundación Española de Hematología y Hemoterapía

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard clinical practice

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Thrombotic thrombocytopenic purpura patients1 intervention

Trial outcomes

Primary outcomes

1

Incidence of TTP in Spain/Portugal

Number of patients diagnosed with TTP and enrolled in the registry per year

Time frame
Throughout the study period, calculated for the 3 years of expected duration.
2

Morbidity of TTP in Spain/Portugal

Percentage of patients diagnosed with TTP and enrolled in the registry among spanish / portuguese population per year

Time frame
Throughout the study period, calculated for the 3 years of expected duration.
3

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

Time frame
Throughout the study period, calculated for the 3 years of expected duration.

Secondary outcomes

1

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.

Time frame
Throughout the study period, approximately 3 years per patient
2

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

Time frame
Throughout the study period, approximately 3 years per patient
3

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

Time frame
Throughout the study period, approximately 3 years per patient
4

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.

Time frame
Throughout the study period, approximately 3 years per patient

Other outcomes

Sponsors and contacts

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