Spanish-Portuguese Thrombotic Thrombocytopenic Purpura Registry

NCT05914441 | Recruiting

• 1 other identifier: RE-PTT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Purpura, Thrombocytopenic

Keywords

registry; Thrombotic thrombocytopenic purpura; real-world; observational

Outcome Measures

Primary Outcomes (3)

• Incidence of TTP in Spain/Portugal

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

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

• Morbidity of TTP in Spain/Portugal

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

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

• 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

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

Secondary Outcomes (12)

• Clinical response to treatment rate

  Throughout the study period, approximately 3 years per patient

• TTP Clinical remission rate

  Throughout the study period, approximately 3 years per patient

• TTP Exacerbation rate

  Throughout the study period, approximately 3 years per patient

• TTP Relapse rate

  Throughout the study period, approximately 3 years per patient

• Refractory TTP rate

  Throughout the study period, approximately 3 years per patient

Study Arms (1)

Thrombotic thrombocytopenic purpura patients

Including all patients enrolled in the study

Other: Standard clinical practice

Interventions

Standard clinical practice 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.

Thrombotic thrombocytopenic purpura patients

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with Thrombotic thrombocytopenic purpura (TTP)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Española de Hematología y Hemoterapía: lead

Study Sites (7)

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

RECRUITING

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Clínic Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

This project will be linked to obtaining biological samples for a serum and DNA library from patients with TTP, to study the impact of the molecular / biological factors on the short and long-term prognosis.

MeSH Terms

Conditions

Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic

Condition Hierarchy (Ancestors)

Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Thrombophilia

Study Officials

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

  Hospital Universitario Virgen del Rocío. Sevilla, España.

  STUDY CHAIR

Central Study Contacts

Contact person Designated by the Sponsor

CONTACT

+34934344412; investigacion@mfar.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: March 22, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

ES (7)