Thrombotic microangiopathy after allogeneic stem cell transplant in adults
Official title: Prospective Study of Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients From Argentina
Run by ITAC (Instituto de Trasplantes y Alta Complejidad) · NCT07059026 · Data updated 2026-11-12
This project will watch adults who receive an allogeneic stem cell transplant to see how often thrombotic microangiopathy happens and how it progresses.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | ITAC (Instituto de Trasplantes y Alta Complejidad) Academic / other |
| Locations | 1 site (Buenos Aires) |
| Status | Recruiting |
| Started | December 3, 2024 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | July 14, 2025 |
| Trial ID | NCT07059026 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) undergoing allogeneic HSCT at participating Argentine centers that perform routine TMA screening and who consent to use of their data for this observational protocol.
✕Probably not a fit
Patients treated outside participating centers, pediatric patients, or those enrolled in interventional TMA treatment trials are unlikely to receive direct benefit from this observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, non-interventional observational study enrolling adults undergoing allogeneic hematopoietic stem cell transplantation in Argentina. Participating centers will perform harmonized routine screening and apply common diagnostic criteria for thrombotic microangiopathy during the first 100 days after transplant. All enrolled patients will be followed every three months up to 12 months post-transplant to capture incidence, timing, clinical course, and secondary outcomes. The protocol uses predefined laboratory and clinical markers for TMA and excludes patients in interventional TMA treatment trials.
Why it matters
Potential benefit: If successful, this work could enable earlier, more consistent detection of TMA after transplant and inform better monitoring and management to reduce organ damage and mortality.
How similar studies have gone: Observational registries and single-center reports have documented post-HSCT TMA, but systematic multicenter adult screening using harmonized criteria is limited, making this approach relatively novel for Argentina.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Instituto de Trasplantes de Alta Complejidad (ITAC)
Buenos Aires, Argentina Recruiting
Study contacts
- Study coordinator: Maria Belen Rosales Ostriz, MD
- Email: belenrosalesostriz@gmail.com
- Phone: +54 9 11 5047-6401
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Iptacopan for high-risk TA-TMA after HSCT
This study tests whether taking iptacopan by mouth can help patients with high-risk transplantation-associated thrombotic microangiopathy after HSCT fail conventional initial care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.