Improving diagnosis and follow-up for patients with Thrombotic Thrombocytopenic Purpura
Improvement of Immunologic and Molecular Techniques for the Diagnosis and Follow-up of Patients With Thrombotic Thrombocytopenic Purpura: a Collaborative Study Proposal of the Spanish Apheresis Group (GEA) in Collaboration With the Spanish Foundation of Hematology and Hemotherapy (FEHH)
This study is testing better ways to diagnose and monitor patients with Thrombotic Thrombocytopenic Purpura to help them get the right treatment faster.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 99 Years |
| Sex | All |
| Sponsor | Fundación Española de Hematología y Hemoterapía Academic / other |
| Locations | 6 sites (Coimbra and 5 other locations) |
| Trial ID | NCT05046717 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on enhancing immunologic and molecular techniques for diagnosing and monitoring patients with acquired Thrombotic Thrombocytopenic Purpura (aTTP). It emphasizes the importance of the ADAMTS13 activity assay, which is critical for the rapid differential diagnosis of aTTP and other thrombotic microangiopathies. By ensuring timely and accurate assessment of ADAMTS13 levels, the study aims to improve patient management and outcomes, particularly in preventing misdiagnosis and delays in treatment. The study will involve patients with confirmed thrombotic microangiopathy and will assess the effectiveness of current diagnostic techniques.
Who should consider this trial
Good fit: Ideal candidates include patients of any age with confirmed thrombotic microangiopathy who meet specific clinical criteria.
Not a fit: Patients without confirmed thrombotic microangiopathy or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of aTTP, improving treatment outcomes and reducing mortality rates.
How similar studies have performed: While the study builds on existing techniques for ADAMTS13 assessment, its specific approach to improving diagnostic accuracy in aTTP is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with confirmed thrombotic microangiopathy (TMA) based on citrated blood samples meeting both of the following criteria: * Thrombocytopenia \[drop in platelet count ≥50% or platelet count \< 100x109/L and * Microangiopathic haemolytic anaemia (elevation of lactate dehydrogenase (LDH) \>2- fold or by presence or increase of schistocytes in peripheral blood smear) * Patients that voluntarily sign informed consent. For subjects unable to provide consent, a fully recognized medical proxy may be used according to local laws. * Patients between 0 to 99 years old at the time of screening. Exclusion Criteria: -
Where this trial is running
Coimbra and 5 other locations
- Centro Hospitalar e Universitario de Coimbra — Coimbra, Portugal (Recruiting)
- Complejo Hospitalario Universitario A Coruña — A Coruña, Spain (Recruiting)
- Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Gregorio Marañon — Madrid, Spain (Recruiting)
- Hospital La Fe de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Cristina Pascual, MD
- Email: cpascuali@salud.madrid.org
- Phone: +34 91 586 8445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.