NCT07059026 Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients
| NCT ID | NCT07059026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ITAC (Instituto de Trasplantes y Alta Complejidad) |
| Condition | Thrombotic Microangiopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-12-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07059026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thrombotic Microangiopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059026 currently recruiting?
Yes, NCT07059026 is actively recruiting participants. Contact the research team at belenrosalesostriz@gmail.com for enrollment information.
Where is the NCT07059026 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT07059026 clinical trial?
NCT07059026 is sponsored by ITAC (Instituto de Trasplantes y Alta Complejidad). The trial plans to enroll 200 participants.