Spanish-Portuguese Thrombotic Thrombocytopenic Purpura Registry

NCT ID: NCT05914441

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-22

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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TTP is a rare life-threatening haematological disease characterised by thrombotic microangiopathy (TMA) with an average annual prevalence of approximately 10 cases/million people worldwide and an annual incidence between 1.5 and 6.0 cases per million according to different studies conducted in France, the United States and in the United Kingdom. In Spain the incidence is 2,67 cases / million population per year.

Acute TTP episodes cause sequelae like vascular disease or kidney damage along with other symptoms more subtle like small neurocognitive deficits and myocardial infarction.

Thus, prompt resolution of acute episodes along with a better understanding of the cardiac abnormalities may allow to prevent further complications, to develop targeted rehabilitation techniques for TTP patients and to improve their quality of life.

This project will collect a big database capable of providing better answers to questions related with treatment efficacy, associated morbidity and mortality, and the possible neurocognitive and cardiac sequelae derived from relapses and acute episodes. Additionally, this project will be linked to obtaining biological samples for a serum and DNA library from patients with TTP.

Patients will be recruited by medical researchers specialized in haematology or by other investigators specialized in thrombotic microangiopathies disease management. This recruitment will be performed in a competitive manner. The collection period will be at least 3 years with the possibility of extending it.

REPTT aims to evaluate new scores and prognostic factors of morbidity and mortality in TTP patients.

The final aim is to establish guidelines and recommendation to improve the global management, diagnosis and treatment of patients with TTP in real-life.

Conditions

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Purpura, Thrombocytopenic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thrombotic thrombocytopenic purpura patients

Including all patients enrolled in the study

Standard clinical practice

Intervention Type OTHER

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.

Interventions

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Standard clinical practice

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with diagnosis of TTP according to International Consensus criteria from centres in Spain and Portugal.
2. 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.
3. Patients between 0 to 99 years old at the time of diagnosis.

Note: Decision was taken to treat the patient with an specific treatment prior and independently of patient inclusion in this non interventional study.

Exclusion Criteria

1. Inability to comply with study procedures and follow-up exams.
2. Patients with any type of alteration that compromises their ability to grant written informed consent.
3. Patients that do not consent to participate in the study and do not sign informed consent.
4. Patients that do not meet the criteria previously mentioned for TTP.
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Española de Hematología y Hemoterapía

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. María Eva Mingot Castellano, M.D. Ph.D.

Role: STUDY_CHAIR

Hospital Universitario Virgen del Rocío. Sevilla, España.

Locations

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Hospital Universitario Virgen del Rocío

Seville, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital Clínic Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Virgen de la Arrixaca

Murcia, , Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Contact person Designated by the Sponsor

Role: CONTACT

+34934344412

Facility Contacts

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A responsible person Designated by the sponsor

Role: primary

934344412

A responsible person Designated by the Sponsor

Role: primary

934344412

A responsible person Designated by the sponsor

Role: primary

934344412

A responsible person Designated by the sponsor

Role: primary

934344412

A responsible person Designated by the sponsor

Role: primary

934344412

A responsible person Designated by the Sponsor

Role: primary

934344412

A responsible person Designated by the sponsor

Role: primary

934344412

Other Identifiers

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RE-PTT

Identifier Type: -

Identifier Source: org_study_id

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