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Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients

Recruitingn/aAges 18 Years - anyAllITAC (Instituto de Trasplantes y Alta Complejidad)
NCT07059026 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Thrombotic Microangiopathy (TMA) Associated with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is a serious complication that is associated with increased morbidity, related to multiple organ failure, with increased mortality in transplant patients. The incidence and evolution of TMA, especially in the adult population, is unclear due to the lack of early systematic screening and clear criteria for its diagnosis. For this reason, we designed this protocol to study the incidence and evolution of TMA Associated with allogeneic HSCT in adult patients from Argentina.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (≥ 18 years) undergoing allogeneic HSCT in specialized centers that, as part of their usual follow-up protocol, carry out basic screening (laboratory/clinical) for TMA and in which patients consent (within the general transplant consent), to have their data used in observational studies. * Patients with ≥ 3/laboratory/clinical diagnostic markers of TMA in two consecutive assessments within 14 days, namely: 1-Elevated Schistocytes in peripheral blood; 2-LDH above the upper normal limit; 3-De novo thrombocytopenia or requirement for platelet transfusion; 4-De novo anemia or requirement for red blood cell transfusion; 5-High blood pressure (≥140/90); 6-Protein/creatinine ratio \> 1mg/mg or proteinuria ≥ 30mg/dl in a random sample). * Patients with suspected/diagnosed TMA who have signed the specific consent for the study. Exclusion Criteria: * Participation in an interventional treatment study of any therapy for TMA.
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What it tests

  • Not listed
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Where

1 site
Instituto de Trasplantes de Alta Complejidad (ITAC)
Buenos Aires, Argentina
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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