Registry for patients with Thrombotic Thrombocytopenic Purpura in Spain and Portugal

Development Of Spanish-Portuguese Thrombotic Thrombocytopenic Purpura Registry (REPTT): A Study Proposal Of The Spanish Society Of Hematology And Hemotherapy (SEHH) Whit The Portuguese Society Of Hematology (SPH)

This study is collecting information from at least 300 patients with Thrombotic Thrombocytopenic Purpura in Spain and Portugal to see how well treatments work and to learn more about the condition.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: N/A to 99 Years
• Sex: All
• Sponsor: Fundación Española de Hematología y Hemoterapía (Academic / other)
• Locations: 7 sites (Seville, Andalusia and 6 other locations)
• Trial ID: NCT05914441 on ClinicalTrials.gov

What this trial studies

This observational registry aims to evaluate at least 300 patients diagnosed with Thrombotic Thrombocytopenic Purpura (TTP) across multiple centers in Spain and Portugal. Conducted under standard clinical practice conditions, the study will collect data on treatment efficacy, morbidity, mortality, and potential neurocognitive and cardiac sequelae associated with TTP. Additionally, biological samples will be obtained to create a serum and DNA library for further research. The goal is to enhance understanding of TTP and improve patient outcomes through better management strategies.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with TTP according to international consensus criteria, aged 0 to 99 years.

Not a fit: Patients who are unable to provide informed consent or do not meet the diagnostic criteria for TTP will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved treatment strategies and quality of life for patients with TTP.

How similar studies have performed: While observational registries for rare diseases like TTP are not common, similar approaches have shown promise in enhancing understanding and treatment of other hematological conditions.

Eligibility criteria

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.

Where this trial is running

Seville, Andalusia and 6 other locations

• Hospital Universitario Virgen del Rocío — Seville, Andalusia, Spain (Recruiting)
• Hospital Universitario Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
• Hospital Clínic Barcelona — Barcelona, Spain (Recruiting)
• Hospital Universitario de Guadalajara — Guadalajara, Spain (Recruiting)
• Hospital Universitario La Paz — Madrid, Spain (Recruiting)
• Hospital Virgen de la Arrixaca — Murcia, Spain (Recruiting)
• Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Contact person Designated by the Sponsor

Conditions Purpura, Thrombocytopenic; registry; Thrombotic thrombocytopenic purpura; real-world; observational