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

Launched by ITAC (INSTITUTO DE TRASPLANTES Y ALTA COMPLEJIDAD) · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a serious condition called Thrombotic Microangiopathy (TMA) that can happen after adults receive a special type of stem cell transplant called an allogeneic hematopoietic stem cell transplant (HSCT). TMA can cause problems in many organs and increase the risk of severe illness or death. Since doctors don’t fully understand how often TMA occurs or how it develops after these transplants, this study aims to find out more by carefully watching and recording cases in adult patients in Argentina.

Adults aged 18 and older who are getting this type of stem cell transplant at certain hospitals that regularly check for signs of TMA may be able to take part. To join, patients need to show at least three signs of TMA during routine tests done twice within two weeks, such as changes in blood cells, high blood pressure, or protein in the urine. People already receiving treatment specifically for TMA in other studies cannot join this one. Participants won’t receive extra treatments as part of this study but will have their health closely monitored to help researchers learn more about TMA. This information could help improve care for future patients undergoing stem cell transplants.

Gender

ALL

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.